Study to Assess Adverse Events and Change in Disease Acti... | NCT05368558 | Trialant
NCT05368558
Sponsor
AbbVie
Status
Terminated
Last Update Posted
Oct 20, 2025Actual
Enrollment
34Actual
Phase
Phase 3
Conditions
Schizophrenia
Interventions
Cariprazine
Placebo
Countries
Japan
Taiwan
Protocol Section
Identification Module
NCT ID
NCT05368558
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M22-509
Secondary IDs
Not provided
Brief Title
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
Official Title
A 6-Week, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Cariprazine in the Acute Exacerbation of Schizophrenia, With an Additional 18-Week Blinded Extension Period
Acronym
509 JPN Schz
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Strategic considerations
Expanded Access Info
No
Start Date
Aug 18, 2022Actual
Primary Completion Date
Sep 20, 2024Actual
Completion Date
Sep 20, 2024Actual
First Submitted Date
May 6, 2022
First Submission Date that Met QC Criteria
May 6, 2022
First Posted Date
May 10, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jul 29, 2025
Results First Submitted that Met QC Criteria
Oct 7, 2025
Results First Posted Date
Oct 20, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 7, 2025
Last Update Posted Date
Oct 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess how safe and effective cariprazine is in treating adult participants with schizophrenia in Japan and Taiwan. Adverse events and change in disease activity will be assessed.
Cariprazine (VRAYLAR) is an approved drug for the treatment of schizophrenia in the United States. In the first 6-week period, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In the next 18-week period, participants will have the option to receive 1 of 3 doses of cariprazine. Approximately 250 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 55 sites across Taiwan and Japan.
Participants will receive oral capsules of Cariprazine or placebo for the 6-week Double-blind Period (DBP). Upon completion of 6-week DBP, participants will be eligible to receive oral capsules of Cariprazine for additional 18 weeks in the Blinded Extension Period (BEP), followed by an 8-week safety follow-up period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Detailed Description
Per the final protocol amendment 3, the number of dosing arms in the 6-week DBP of the study changed from 3 to 2. Participants enrolled in the study through Protocol Amendment 2 and who were randomized to the arm that was eliminated, remained in that arm through DBP and their data are displayed by that arm for the DBP portion of the study in participant flow, baseline characteristics and safety sections. Data for all endpoints are presented as planned per final SAP.
Conditions Module
Conditions
Schizophrenia
Keywords
Schizophrenia
Cariprazine
VRAYLAR
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
34Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cariprazine
Experimental
Participants will receive cariprazine Dose A daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
Drug: Cariprazine
Placebo
Placebo Comparator
Participants will receive placebo daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
Drug: Cariprazine
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cariprazine
Drug
Oral Capsule
Cariprazine
Placebo
VRAYLAR
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)
Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Baseline (Wk 0) to Week 6
Secondary Outcomes
Measure
Description
Time Frame
Change in CGI-S Score From Baseline (Wk 0) to Week 6
Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed with schizophrenia at least 1 year before informed consent.
Experienced a persistent psychotic episode within 2 months prior to informed consent requiring treatment modifications as judged by the investigator or sub-investigator.
Exclusion Criteria:
- History of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
Accepts Healthy Volunteers
No
Sex
All
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
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Akita University Hospital /ID# 245941
Akita
Akita
010-8543
Japan
International University of Health and Welfare Narita Hospital /ID# 243870
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6-week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Baseline (Wk 0) to Week 6
Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6
Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.
Baseline (Wk 0) to Week 6
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Baseline (Wk 0) to Week 6
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Baseline (Wk 0) to Week 6
Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Baseline (Wk 0) and Week 6 to Week 24
Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24
Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.
Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Baseline (Wk 0) and Week 6 to Week 24
Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24
Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.
Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Baseline (Wk 0) and Week 6 to Week 24
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
Baseline (Wk 0) and Week 6 to Week 24
Narita-shi
Chiba
2868520
Japan
Fukuoka University Hospital /ID# 244404
Fukuoka
Fukuoka
814-0180
Japan
Kuramitsu Hospital /ID# 242511
Fukuoka
Fukuoka
819-0037
Japan
Shiranui Hospital /ID# 243717
Omuta-shi
Fukuoka
836-0004
Japan
Gifu University Hospital /ID# 246238
Gifu
Gifu
501-1194
Japan
Holy Cross Hospital /ID# 242673
Toki-shi
Gifu
509-5142
Japan
Hayakawa Clinic /ID# 242432
Kure
Hiroshima
737-0111
Japan
National Hospital Organization Kure Medical Center /ID# 243405
Kure-shi
Hiroshima
737-0023
Japan
Goryokai Hospital /ID# 242420
Sapporo
Hokkaido
002-8029
Japan
Sapporo Medical University Hospital /ID# 245135
Sapporo
Hokkaido
060-8543
Japan
Duplicate_Hokkaido University Hospital /ID# 243245
Sapporo
Hokkaido
060-8648
Japan
Kagawa University Hospital /ID# 243772
Kita-gun
Kagawa-ken
761-0793
Japan
Taniyama Hospital /ID# 242385
Kagoshima
Kagoshima-ken
891-0111
Japan
Yokohama City University Hospital /ID# 244944
Yokohama
Kanagawa
236-0004
Japan
Yuge Hospital /ID# 242849
Kumamoto
Kumamoto
861-8002
Japan
Duplicate_University Hospital Kyoto Prefectural University of Medicine /ID# 242443
National Center of Neurology and Psychiatry /ID# 242677
Kodaira-shi
Tokyo
187-8551
Japan
Tokyo Metropolitan Matsuzawa Hospital /ID# 245272
Setagaya-ku
Tokyo
156-0057
Japan
Wakayama Medical University Hospital /ID# 251105
Wakayama
Wakayama
641-8510
Japan
Shin-abuyama Hospital /ID# 243138
Takatsuki
569-1041
Japan
Minamitoyama Nakagawa Hospital /ID# 243616
Toyama
939-8073
Japan
Kaohsiung Municipal Kai-Syuan Psychiatric Hospital /ID# 241533
Kaohsiung City
Kaohsiung
802
Taiwan
Bali Psychiatric Center /ID# 241597
New Taipei City
New Taipei
249
Taiwan
Taipei Veterans General Hospital /ID# 241522
Taipei City
Taipei
11217
Taiwan
Changhua Christian Hospital /ID# 241524
Changhua City, Changhua County
50006
Taiwan
National Taiwan University Hospital - Yunlin Branch /ID# 241537
Douliu
640
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 241528
Kaohsiung City
807
Taiwan
TsaoTun Psychiatric Center, MOHW /ID# 246012
Nantou City
54249
Taiwan
New Taipei Municipal TuCheng Hospital (Built and Operated by Chang Gung Medical /ID# 243653
New Taipei City
236
Taiwan
Chung Shan Medical University Hospital /ID# 241543
Taichung
40201
Taiwan
Taichung Veterans General Hospital /ID# 246200
Taichung
40705
Taiwan
Jianan Psychiatric Center, Ministry of Health and Welfare /ID# 241540
Tainan
71742
Taiwan
Taipei City Hospital, Songde Branch /ID# 241600
Taipei
110
Taiwan
Tri-Service General Hospital Beitou Branch /ID# 241563
Taipei
112
Taiwan
Taoyuan Psychiatric Center, MOHW /ID# 241691
Taoyuan
33058
Taiwan
Linkou Chang Gung Memorial Hospital /ID# 241520
Taoyuan City
333
Taiwan
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
FG002
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
FG003
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=10 from DBP Placebo
FG004
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=1 from DBP Placebo N=2 from DBP Cariprazine 3 mg N=1 from DBP Cariprazine 6 mg
FG005
BEP Cariprazine 6 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal daily dose during the 18-week BEP.
Number of participants entered into this arm consisted of:
N=2 from DBP Cariprazine 3 mg N=8 from DBP Cariprazine 6 mg
FG006
SF DBP Placebo
Safety Follow up (SF) for DBP Placebo participants.
FG007
SF DBP Cariprazine 3 mg
SF for DBP Cariprazine 3 mg participants.
FG008
SF DBP Cariprazine 6 mg
SF for DBP Cariprazine 6 mg participants.
FG009
SF BEP Cariprazine 1.5 mg
SF for BEP Cariprazine 1.5 mg participants.
FG010
SF BEP Cariprazine 3 mg
SF for BEP Cariprazine 3 mg participants.
FG011
SF BEP Cariprazine 6 mg
SF for BEP Cariprazine 6 mg participants.
FG00016 subjects
FG0015 subjects
FG00213 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG00015 subjects
FG0014 subjects
FG00211 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Blinded Extension Period (BEP)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00310 subjects
FG0044 subjects
FG00510 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0038 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety Follow-up DBP (SF DBP)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00615 subjects
FG0074 subjects
FG00811 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety Follow-up BEP (SF BEP)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00910 subjects
FG0104 subjects
FG01110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 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 study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
BG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
BG002
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG0015
BG00213
BG00334
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
BG00042.2± 11.76
BG00140.4± 13.70
BG00243.7± 10.88
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
SCI-PANSS Total Score at Baseline
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). The SCI-PANSS total score can range from 30 to 210. Higher values represent a worse outcome.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
Title
Measurements
BG00094.6± 8.70
BG001
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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Safety Population includes all randomized participants who receive at least 1 dose of study drug.
Posted
Count of Participants
Participants
From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)
ID
Title
Description
OG000
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
OG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
OG002
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Units
Counts
Participants
OG00016
OG0015
OG00213
Title
Denominators
Categories
Title
Measurements
OG00012
OG0012
OG00210
Primary
Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) to Week 6
ID
Title
Description
OG000
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
OG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Secondary
Change in CGI-S Score From Baseline (Wk 0) to Week 6
Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.
mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) to Week 6
ID
Title
Description
OG000
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
OG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
OG002
Secondary
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) to Week 6
ID
Title
Description
OG000
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
OG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Secondary
Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6
Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.
mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) to Week 6
ID
Title
Description
OG000
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
OG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
OG002
Secondary
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) to Week 6
ID
Title
Description
OG000
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
OG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Secondary
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
mITT Population includes all randomized participants who receive at least 1 dose of study drug and have both baseline and at least 1 postbaseline value during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) to Week 6
ID
Title
Description
OG000
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
OG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Secondary
Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) and Week 6 to Week 24
ID
Title
Description
OG000
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
OG001
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
Secondary
Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24
Clinical Global Impression-Severity (CGI-S) is a single, clinician-reported item that measures the clinician's impression of a participant's current anxiety severity considering their total clinical experience with the patient population. The measure uses a 7-point Likert rating scale with responses ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The total CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change from baseline indicates improvement.
BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) and Week 6 to Week 24
ID
Title
Description
OG000
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
OG001
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
OG002
BEP Cariprazine 6 mg
Secondary
Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) and Week 6 to Week 24
ID
Title
Description
OG000
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
OG001
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
Secondary
Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24
Negative Symptom Assessment-16 (NSA-16) is a 16-item clinician-reported scale covering 5 areas or domains: communication, affect, social involvement, motivation, and retardation. It is designed to assess negative symptoms of patients with schizophrenia. Each item or behavior is rated on a 6-point scale ranging from 1 (not reduced) to 6 (severely reduced or absent). Higher values represent a worse outcome. The total NSA-16 score can range from 16 to 96. A negative change from baseline indicates improvement.
BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) and Week 6 to Week 24
ID
Title
Description
OG000
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
OG001
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
OG002
BEP Cariprazine 6 mg
Secondary
Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) and Week 6 to Week 24
ID
Title
Description
OG000
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
OG001
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
Secondary
Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
BEP population consisted of all participants who complete the 6-week DBP and received at least 1 dose of study drug during the BEP regardless of which treatment group they were randomized to during the DBP.
Posted
Mean
Standard Deviation
score on a scale
Baseline (Wk 0) and Week 6 to Week 24
ID
Title
Description
OG000
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal (most frequent) daily dose during the 18-week BEP.
OG001
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal daily dose during the 18-week BEP.
Time Frame
All-cause mortality were reported from enrollment to the end of study. In the DBP, median time on follow up (median time subjects were followed) was 42.0 days (d) for all arms (DBP: Pbo, C 3mg, and C 6mg). In the BEP, median time on follow up was 117.5, 126.0, and 97.5d for BEP: C1.5mg, C 3mg, and C 6mg, respectively. In the SF DBP, median time on follow up was 57.0, 1.0, and 47.0d for SF DBP: Pbo, C 3mg, and C 6mg, respectively.
Description
In the SF BEP, median time on follow up was 56.0, 57.0, and 56.5d for SF BEP: C1.5mg, C 3mg, and C 6mg, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 8 weeks after the last dose of study drug. Mean duration on study drug was 36.4, 41.8, and 38.9d for DBP: Pbo, C 3mg, and C 6mg, respectively. Mean duration on study drug was 88.2,108.5, and 87.1d for BEP: C1.5mg, C 3mg, and C 6mg, respectively.
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
DBP Placebo
Participants received Placebo oral capsule daily for the 6-week Double Blind Period (DBP). Upon completion of 6week DBP, participants had the option to receive Cariprazine 1.5 mg oral capsule daily for an 18-week Blinded Extension Period (BEP).
0
16
0
16
12
16
EG001
DBP Cariprazine 3 mg
Participants received Cariprazine 3 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
0
5
0
5
2
5
EG002
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
0
13
0
13
10
13
EG003
BEP Cariprazine 1.5 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 1.5 mg modal modal (most frequent) daily dose during the 18-week BEP.
0
10
1
10
7
10
EG004
BEP Cariprazine 3 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 3 mg modal modal (most frequent) daily dose during the 18-week BEP.
0
4
1
4
3
4
EG005
BEP Cariprazine 6 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal (most frequent) daily dose during the 18-week BEP.
0
10
0
10
6
10
EG006
SF DBP Placebo
Safety Follow up (SF) for DBP Placebo participants.
0
5
0
5
3
5
EG007
SF DBP Cariprazine 3 mg
SF for DBP Cariprazine 3 mg participants.
0
1
0
1
0
1
EG008
SF DBP Cariprazine 6 mg
SF for DBP Cariprazine 6 mg participants.
0
4
1
4
2
4
EG009
SF BEP Cariprazine 1.5 mg
SF for BEP Cariprazine 1.5 mg participants.
0
10
0
10
4
10
EG010
SF BEP Cariprazine 3 mg
SF for BEP Cariprazine 3 mg participants.
0
4
1
4
0
4
EG011
SF BEP Cariprazine 6 mg
SF for BEP Cariprazine 6 mg participants.
0
10
0
10
2
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
AGITATION
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
SCHIZOPHRENIA
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
DRY EYE
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected10 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected10 at risk
IRIDOCYCLITIS
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
UVEITIS
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected13 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected13 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
FEELING ABNORMAL
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
PYREXIA
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
HORDEOLUM
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
PERIODONTITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
CHILLBLAINS
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
IMMUNISATION REACTION
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
POST VACCINATION SYNDROME
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
POST-TRAUMATIC PAIN
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
SKIN ABRASION
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
WOUND
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
BLOOD CHLORIDE DECREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
BLOOD SODIUM DECREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
HIGH DENSITY LIPOPROTEIN INCREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
WHITE BLOOD CELL COUNT INCREASED
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected13 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
AKATHISIA
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0024 events4 affected13 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
EXTRAPYRAMIDAL DISORDER
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected13 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
PARKINSONISM
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
TREMOR
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected13 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected13 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0022 events2 affected13 at risk
EG003
LOGORRHOEA
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
NIGHTMARE
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected13 at risk
EG003
RESTLESSNESS
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
SCHIZOPHRENIA
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected16 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected13 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
SCROTAL ERYTHEMA
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
DERMATITIS
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
DERMATITIS ATOPIC
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
SKIN FISSURES
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected13 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected13 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Schizophrenia Spectrum and Other Psychotic Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C533287
cariprazine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
FG0057 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
1 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0065 subjects
FG0071 subjects
FG0084 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG00610 subjects
FG0073 subjects
FG0087 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00910 subjects
FG0104 subjects
FG01110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
42.5
± 11.40
6
BG00313
Male
BG00010
BG0014
BG0027
BG00321
0
BG0030
Not Hispanic or Latino
BG00016
BG0015
BG00213
BG00334
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
0
BG0030
Asian
BG00016
BG0015
BG00213
BG00334
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG0000
BG0010
BG0020
BG0030
White
BG0000
BG0010
BG0020
BG0030
More than one race
BG0000
BG0010
BG0020
BG0030
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
99.8
± 8.17
BG00291.8± 7.37
BG00394.3± 8.33
OG002
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Units
Counts
Participants
OG00011
OG0015
OG00210
Title
Denominators
Categories
Title
Measurements
OG000-15.2± 12.21
OG001-5.6± 10.38
OG002-30.2± 17.47
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
Mean Difference (Final Values)
9.6
2-Sided
95
-4.0
23.1
Superiority
OG000
OG002
Mean Difference (Final Values)
-15.0
2-Sided
95
-28.7
-1.4
Superiority
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Units
Counts
Participants
OG00011
OG0015
OG00210
Title
Denominators
Categories
Title
Measurements
OG000-0.6± 0.92
OG001-0.4± 0.55
OG002-1.3± 1.25
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
Mean Difference (Final Values)
0.2
2-Sided
95
-0.7
1.2
Superiority
OG000
OG002
Mean Difference (Final Values)
-0.7
2-Sided
95
-1.7
0.3
Superiority
OG002
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Units
Counts
Participants
OG00011
OG0015
OG00210
Title
Denominators
Categories
Title
Measurements
OG000-4.7± 4.67
OG001-2.2± 3.35
OG002-8.7± 4.00
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
Mean Difference (Final Values)
2.5
2-Sided
95
-2.5
7.5
Superiority
OG000
OG002
Mean Difference (Final Values)
-4.0
2-Sided
95
-8.0
0.0
Superiority
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Units
Counts
Participants
OG00011
OG0015
OG00210
Title
Denominators
Categories
Title
Measurements
OG000-3.2± 7.49
OG001-2.8± 9.20
OG002-14.5± 8.28
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
Mean Difference (Final Values)
0.4
2-Sided
95
-8.9
9.7
Superiority
OG000
OG002
Mean Difference (Final Values)
-11.3
2-Sided
95
-18.5
-4.1
Superiority
OG002
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Units
Counts
Participants
OG00011
OG0015
OG00210
Title
Denominators
Categories
Title
Measurements
OG000-3.5± 3.86
OG001-0.2± 3.27
OG002-8.1± 5.30
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
Mean Difference (Final Values)
3.3
2-Sided
95
-1.0
7.5
Superiority
OG000
OG002
Mean Difference (Final Values)
-4.6
2-Sided
95
-8.9
-0.4
Superiority
OG002
DBP Cariprazine 6 mg
Participants received Cariprazine 6 mg oral capsule daily for the 6-week DBP. Upon completion of 6-week DBP, participants had the option to receive Cariprazine 3 mg oral capsule daily for the 18-week BEP.
Units
Counts
Participants
OG00011
OG0015
OG00210
Title
Denominators
Categories
Title
Measurements
OG000-3.8± 3.71
OG001-0.4± 3.78
OG002-9.1± 6.82
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
Mean Difference (Final Values)
3.4
2-Sided
95
-0.9
7.7
Superiority
OG000
OG002
Mean Difference (Final Values)
-5.3
2-Sided
95
-10.2
-0.3
Superiority
OG002
BEP Cariprazine 6 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.
Units
Counts
Participants
OG0005
OG0013
OG0024
Title
Denominators
Categories
Baseline (Wk 0) to Week 24
Title
Measurements
OG000-19.2± 19.52
OG001-19.3± 30.09
OG002-22.5± 25.16
Week 6 to Week 24
Title
Measurements
OG000-4.0± 16.05
OG0012.0± 4.58
OG0026.0± 17.51
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.
Units
Counts
Participants
OG0005
OG0013
OG0024
Title
Denominators
Categories
Baseline (Wk 0) to Week 24
Title
Measurements
OG000-0.8± 0.84
OG001-1.3± 2.31
OG002-1.0± 0.82
Week 6 to Week 24
Title
Measurements
OG000-0.4± 1.14
OG0010.0± 0.00
OG0020.0± 0.82
OG002
BEP Cariprazine 6 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.
Units
Counts
Participants
OG0005
OG0013
OG0024
Title
Denominators
Categories
Baseline (Wk 0) to Week 24
Title
Measurements
OG000-5.2± 5.36
OG001-4.3± 7.51
OG002-6.8± 6.60
Week 6 to Week 24
Title
Measurements
OG000-0.2± 4.38
OG0010.3± 0.58
OG0021.5± 6.03
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.
Units
Counts
Participants
OG0005
OG0013
OG0024
Title
Denominators
Categories
Baseline (Wk 0) to Week 24
Title
Measurements
OG000-11.6± 13.52
OG001-5.0± 14.00
OG002-13.3± 20.19
Week 6 to Week 24
Title
Measurements
OG000-7.6± 18.28
OG0012.7± 5.51
OG002-1.8± 11.18
OG002
BEP Cariprazine 6 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.
Units
Counts
Participants
OG0005
OG0013
OG0024
Title
Denominators
Categories
Baseline (Wk 0) to Week 24
Title
Measurements
OG000-6.4± 3.85
OG001-5.0± 6.24
OG002-5.3± 9.64
Week 6 to Week 24
Title
Measurements
OG000-2.8± 4.09
OG001-1.3± 2.52
OG0022.3± 4.19
OG002
BEP Cariprazine 6 mg
Participants who complete the 6-week DBP and moved on to received Cariprazine 6 mg modal modal daily dose during the 18-week BEP.