Study Evaluating Vabicaserin in Subjects With Schizophrenia | NCT00563706 | Trialant
NCT00563706
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 20, 2014Estimated
Enrollment
199Actual
Phase
Phase 2
Conditions
Schizophrenia
Interventions
vabicaserin
risperidone
placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00563706
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3153A1-2203
Secondary IDs
ID
Type
Description
Link
B1911032
Brief Title
Study Evaluating Vabicaserin in Subjects With Schizophrenia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Feb 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2007
Primary Completion Date
Jun 2008Actual
Completion Date
Jun 2008Actual
First Submitted Date
Nov 21, 2007
First Submission Date that Met QC Criteria
Nov 21, 2007
First Posted Date
Nov 26, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 3, 2014
Results First Submitted that Met QC Criteria
Feb 3, 2014
Results First Posted Date
Mar 20, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 23, 2009
Certification/Extension First Submitted that Passed QC Review
May 13, 2010
Certification/Extension First Posted Date
May 14, 2010Estimated
Last Update Submitted Date
Feb 3, 2014
Last Update Posted Date
Mar 20, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.
Detailed Description
Not provided
Conditions Module
Conditions
Schizophrenia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
199Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Drug: vabicaserin
2
Active Comparator
4mg/day
Drug: risperidone
3
Placebo Comparator
matching placebo
Other: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
vabicaserin
Drug
This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Baseline
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Baseline, Day 28
Secondary Outcomes
Measure
Description
Time Frame
Positive and Negative Symptom Scale (PANSS) Positive Subscale Score
PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Generally healthy, men and women, aged 18 to 65.
Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.
Exclusion Criteria:
Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfizer Investigational Site
Little Rock
Arkansas
72201
United States
Pfizer Investigational Site
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
A total of 204 participants were randomized, of which 202 participants received at least 1 dose of double-blind test article.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
Positive and Negative Symptom Scale (PANSS) Negative Subscale Score
PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.
Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score
General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.
Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score
Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.
Baseline, Day 7, 14, 21, 28
Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score
Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Baseline, Day 7, 14, 21, 28
Clinical Global Impression - Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Baseline, Day 7, 14, 21, 28
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).
Day 7, 14, 21, 28
Calgary Depression Scale for Schizophrenia (CDSS) Score
CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.
Baseline, Day 7, 14, 21, 28
Cerritos
California
90703
United States
Pfizer Investigational Site
Escondido
California
92025
United States
Pfizer Investigational Site
Garden Grove
California
92845
United States
Pfizer Investigational Site
Glendale
California
91206
United States
Pfizer Investigational Site
San Diego
California
92103
United States
Pfizer Investigational Site
San Diego
California
92123
United States
Pfizer Investigational Site
Torrance
California
90502
United States
Pfizer Investigational Site
Washington D.C.
District of Columbia
20016
United States
Pfizer Investigational Site
Aventura
Florida
33180
United States
Pfizer Investigational Site
Hollywood
Florida
33021
United States
Pfizer Investigational Site
Kissimmee
Florida
34741
United States
Pfizer Investigational Site
Hoffman Estates
Illinois
60169
United States
Pfizer Investigational Site
Indianapolis
Indiana
46222
United States
Pfizer Investigational Site
Lake Charles
Louisiana
70601
United States
Pfizer Investigational Site
Baltimore
Maryland
21202
United States
Pfizer Investigational Site
Rockville
Maryland
20850
United States
Pfizer Investigational Site
Hamilton
New Jersey
08619
United States
Pfizer Investigational Site
Willingboro
New Jersey
08046
United States
Pfizer Investigational Site
Cedarhurst
New York
11516
United States
Pfizer Investigational Site
Holliswood
New York
11423
United States
Pfizer Investigational Site
New York
New York
10032
United States
Pfizer Investigational Site
Butner
North Carolina
27509
United States
Pfizer Investigational Site
Oklahoma City
Oklahoma
73103
United States
Pfizer Investigational Site
Philadelphia
Pennsylvania
19131
United States
Pfizer Investigational Site
Austin
Texas
78754
United States
Pfizer Investigational Site
Austin
Texas
78756
United States
Pfizer Investigational Site
Bellaire
Texas
77008
United States
Pfizer Investigational Site
DeSoto
Texas
75115
United States
Pfizer Investigational Site
Houston
Texas
77008
United States
Pfizer Investigational Site
Arlington
Virginia
22201
United States
Pfizer Investigational Site
Portsmouth
Virginia
23707
United States
Pfizer Investigational Site
Kingston
Ontario
K7L 4X3
Canada
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
FG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
FG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
FG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
FG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
FG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
FG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
FG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
FG00037 subjects
FG00118 subjects
FG0028 subjects
FG00319 subjects
FG00416 subjects
FG00519 subjects
FG00612 subjects
FG00730 subjects
FG00843 subjects
COMPLETED
FG00020 subjects
FG00113 subjects
FG0023 subjects
FG0039 subjects
FG00411 subjects
FG00514 subjects
FG0069 subjects
FG00716 subjects
FG00832 subjects
NOT COMPLETED
FG00017 subjects
FG0015 subjects
FG0025 subjects
FG00310 subjects
FG0045 subjects
FG0055 subjects
FG0063 subjects
FG00714 subjects
FG00811 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0085 subjects
Lack of Efficacy
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0034 subjects
FG004
Withdrawal by Subject
FG0009 subjects
FG0013 subjects
FG0022 subjects
FG0035 subjects
FG004
Discontinuation of Study by Sponsor
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Taper Phase (Day 29 up to Day 35)
Type
Comment
Milestone Data
STARTED
FG00020 subjects
FG00113 subjects
FG0023 subjects
FG0039 subjects
FG00411 subjects
FG00514 subjects
FG0069 subjects
FG00716 subjects
FG00832 subjects
COMPLETED
FG00020 subjects
FG00113 subjects
FG0023 subjects
FG0039 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety population included all randomized participants who received at least 1 dose of double-blind test article.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
BG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
BG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
BG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
BG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
BG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
BG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
BG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
BG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00037
BG00118
BG0028
BG00319
BG00416
BG00519
BG00612
BG00730
BG00843
BG009202
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.05± 9.88
BG00143.22± 10.17
BG00241.25± 4.89
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score.
Posted
Mean
Standard Deviation
units on a scale
Baseline
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG00035
OG00117
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00094.74± 11.18
OG00194.24± 8.42
OG00296.88± 14.54
OG003
Primary
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
mITT population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Day 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
Secondary
Positive and Negative Symptom Scale (PANSS) Positive Subscale Score
PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Posted
Baseline, Day 7, 14, 21, 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG002
Secondary
Positive and Negative Symptom Scale (PANSS) Negative Subscale Score
PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Posted
Baseline, Day 7, 14, 21, 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
Secondary
Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score
General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Posted
Baseline, Day 7, 14, 21, 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
Secondary
Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score
Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Posted
Baseline, Day 7, 14, 21, 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
Secondary
Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score
Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Posted
Baseline, Day 7, 14, 21, 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
Secondary
Clinical Global Impression - Severity (CGI-S) Score
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Posted
Baseline, Day 7, 14, 21, 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
Secondary
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Posted
Day 7, 14, 21, 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
Secondary
Calgary Depression Scale for Schizophrenia (CDSS) Score
CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Posted
Baseline, Day 7, 14, 21, 28
ID
Title
Description
OG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG002
Vabicaserin 100 mg
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
4
37
28
37
EG001
Vabicaserin 50 mg
One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
0
18
12
18
EG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1
8
6
8
EG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
0
19
11
19
EG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
0
16
13
16
EG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1
19
13
19
EG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
2
12
10
12
EG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
2
30
23
30
EG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
3
43
35
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Respiratory tract infection
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG0030 affected19 at risk
EG004
Agitation
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Depression
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Homicidal ideation
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Schizophrenia, undifferentiated type
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Hypotension
Vascular disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG0030 affected19 at risk
EG0040 affected16 at risk
EG0051 affected19 at risk
EG0060 affected12 at risk
EG0070 affected30 at risk
EG0080 affected43 at risk
Tachycardia
Cardiac disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Dry eye
Eye disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Gaze palsy
Eye disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Photophobia
Eye disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Vision blurred
Eye disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0005 affected37 at risk
EG0012 affected18 at risk
EG0020 affected8 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0003 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0003 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0012 affected18 at risk
EG0021 affected8 at risk
EG003
Asthenia
General disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Gait disturbance
General disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Pain
General disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Pitting oedema
General disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Sluggishness
General disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Localised infection
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Sexually transmitted disease
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Medical device complication
Injury, poisoning and procedural complications
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Weight decreased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Weight increased
Investigations
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Sensation of heaviness
Musculoskeletal and connective tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Choreoathetosis
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Drooling
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0012 affected18 at risk
EG0020 affected8 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0003 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0005 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Sedation
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Tardive dyskinesia
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Tremor
Nervous system disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0003 affected37 at risk
EG0011 affected18 at risk
EG0021 affected8 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0012 affected18 at risk
EG0020 affected8 at risk
EG003
Bruxism
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 6.1
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Galactorrhoea
Reproductive system and breast disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0002 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected18 at risk
EG0020 affected8 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0021 affected8 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 6.1
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected18 at risk
EG0020 affected8 at risk
EG003
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D012559
Schizophrenia
Ancestor Terms
ID
Term
D019967
Schizophrenia Spectrum and Other Psychotic Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C556517
vabicaserin
D018967
Risperidone
Ancestor Terms
ID
Term
D011744
Pyrimidinones
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0052 subjects
FG0062 subjects
FG0075 subjects
FG0081 subjects
4 subjects
FG0053 subjects
FG0061 subjects
FG0076 subjects
FG0083 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0082 subjects
11 subjects
FG00514 subjects
FG0069 subjects
FG00716 subjects
FG00832 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
40.53
± 11.43
BG00442.94± 8.27
BG00540.74± 10.29
BG00638.17± 9.73
BG00743.60± 9.25
BG00842.72± 9.93
BG00942.07± 9.67
1
BG0034
BG0045
BG0053
BG0060
BG0076
BG00810
BG00941
Male
BG00029
BG00114
BG0027
BG00315
BG00411
BG00516
BG00612
BG00724
BG00833
BG009161
18
OG00416
OG00518
OG00612
OG00728
OG00842
101.33
± 12.97
OG00493.06± 8.84
OG00594.39± 8.73
OG00692.83± 10.25
OG00795.54± 12.46
OG00891.43± 10.83
OG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG00021
OG00113
OG0023
OG00310
OG00411
OG00514
OG0069
OG00717
OG00832
Title
Denominators
Categories
Title
Measurements
OG000-17.03± 3.59
OG001-4.72± 4.87
OG002-10.26± 8.35
OG003-5.41± 5.18
OG004-13.42± 5.17
OG005-6.13± 4.80
OG006-13.84± 5.93
OG007-7.30± 4.09
OG008-15.59± 3.20
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Mixed Models Analysis
0.043
Least Squares (LS) Mean Difference
-12.30
2-Sided
95
-24.24
-0.37
No
Superiority or Other
OG000
OG002
Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Mixed Models Analysis
0.457
LS Mean Difference
-6.77
2-Sided
95
-24.70
11.16
No
Superiority or Other
OG000
OG003
Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Mixed Models Analysis
0.067
LS Mean Difference
-11.61
2-Sided
95
-24.03
0.81
No
Superiority or Other
OG000
OG004
Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Mixed Models Analysis
0.567
LS Mean Difference
-3.61
2-Sided
95
-16.02
8.80
No
Superiority or Other
OG000
OG005
Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Mixed Models Analysis
0.070
LS Mean Difference
-10.90
2-Sided
95
-22.71
0.92
No
Superiority or Other
OG000
OG006
Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Mixed Models Analysis
0.647
LS Mean Difference
-3.18
2-Sided
95
-16.87
10.50
No
Superiority or Other
OG000
OG007
Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Mixed Models Analysis
0.075
LS Mean Difference
-9.73
2-Sided
95
-20.46
1.00
No
Superiority or Other
OG000
OG008
Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Mixed Models Analysis
0.765
LS Mean Difference
-1.44
2-Sided
95
-10.92
8.04
No
Superiority or Other
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Vabicaserin 100 mg
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG003
Vabicaserin 150 mg
One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
OG004
Vabicaserin 200 mg
Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG005
Vabicaserin 300 mg
Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
OG006
Vabicaserin 400 mg
Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG007
Vabicaserin 600 mg
Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
OG008
Risperidone
One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.