Lurasidone HCl A Phase 3 Study of Patients With Acute Sch... | NCT00615433

Status Module

Label	Type	Intervention Names
Lurasdione 40mg tablets	Experimental	Drug: Lurasidone 40 mg tablets
120mg	Experimental	Drug: Lurasidone
15mg Olz	Active Comparator	Drug: Olanzapine
Sugar pill	Placebo Comparator	Drug: Placebo comparator

Name	Type	Description	Arm Group Labels	Other Names
Lurasidone	Drug	120mg/day	120mg
Olanzapine

Measure	Description	Time Frame
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.	The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.	Baseline and 6 weeks

Measure	Description	Time Frame
CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.	The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.	6 weeks

Eligibility Module

Name	Affiliation	Role
Medical Director, MD	Sumitomo Pharma America, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
K&S Professional Research Services LLC		Little Rock	Arkansas	72201	United States
Woodland International Research Group, LLC

PubMed Identifier	Type	Citation	Retractions
21676992	Background	Meltzer HY, Cucchiaro J, Silva R, Ogasa M, Phillips D, Xu J, Kalali AH, Schweizer E, Pikalov A, Loebel A. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011 Sep;168(9):957-67. doi: 10.1176/appi.ajp.2011.10060907. Epub 2011 Jun 15.
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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	40mg	Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	40mg	Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
BG001	120mg	3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
BG002	15mg Olz	3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
BG003	Placebo	Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
BG004	Total	Total of all reporting groups

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

Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.

The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.

The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.

Posted

Nov 2010

Least Squares Mean

95% Confidence Interval

Units on a scale

Baseline and 6 weeks

ID	Title	Description
OG000	40mg	Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
OG001	120mg	3 40 mg tablets taken orally once a day.
OG002	15mg Olz	3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
OG003	Placebo	Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).

Units	Counts
Participants	OG000118 OG001118 OG002121 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-25.7(-29.6 to -21.8) OG001-23.6(-27.8 to -19.4) OG002-28.7(-32.4 to -24.9) OG003

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 OG003	Improvements in PANSS ratings are estimated from 2 prior studies of lurasidone. Assuming lurasidone differs from placebo in change from baseline in PANSS by 6.8 and 10.0 for 40 and 120 mg, respectively, and assuming a standard deviation of 19.1, then n=120 subjects per group provides approximately 97% power (at α=0.05, two-sided) to reject the null hypothesis of no difference from placebo for at least 1 dose. This calculation uses Bonferroni's procedure for controlling pairwise differences.	Mixed Models Analysis		<0.05						2-Sided	95						No	Superiority or Other

Secondary

CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.

The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.

Posted

Least Squares Mean

95% Confidence Interval

scale

6 weeks

ID	Title	Description
OG000	40mg	Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
OG001	120mg	3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	40mg	Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.	2	119	90	119
EG001	120mg	3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.	6	118	96	118
EG002	15mg Olz	3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.	5	122	98	122
EG003	Placebo	Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).	5	116	84	116

Serious Adverse Events

Term	Organ System	Statistical Information
Acute Myocardial Infarction	Cardiac disorders	EG0000 affected119 at risk EG0010 affected118 at risk EG0020 affected122 at risk EG0031 affected116 at risk
Angina Pectoris	Cardiac disorders	EG0000 affected119 at risk EG0010 affected118 at risk EG0020 affected122 at risk EG003
Sinus Tachycardia	Cardiac disorders	EG0000 affected119 at risk EG0010 affected118 at risk EG0021 affected122 at risk EG003
Heamatemesis	Gastrointestinal disorders	EG0000 affected119 at risk EG0010 affected118 at risk EG0020 affected122 at risk EG003
Hepatitis	Hepatobiliary disorders	EG0000 affected119 at risk EG0010 affected118 at risk EG0021 affected122 at risk EG003
Bronchopneumonia	Infections and infestations	EG0000 affected119 at risk EG0010 affected118 at risk EG0021 affected122 at risk EG003
Agitation	Psychiatric disorders	EG0001 affected119 at risk EG0010 affected118 at risk EG0020 affected122 at risk EG003
Panic Attack	Psychiatric disorders	EG0000 affected119 at risk EG0010 affected118 at risk EG0020 affected122 at risk EG003
Psychotic Disorder	Psychiatric disorders	EG0000 affected119 at risk EG0014 affected118 at risk EG0021 affected122 at risk EG003
Schizophrenia	Psychiatric disorders	EG0001 affected119 at risk EG0012 affected118 at risk EG0021 affected122 at risk EG003
Substance Abuse	Psychiatric disorders	EG0001 affected119 at risk EG0010 affected118 at risk EG0020 affected122 at risk EG003
Suicidal Ideation	Psychiatric disorders	EG0001 affected119 at risk EG0011 affected118 at risk EG0021 affected122 at risk EG003

Other Adverse Events

Term	Organ System	Statistical Information
Constipation	Gastrointestinal disorders	EG0006 affected119 at risk EG0019 affected118 at risk EG0028 affected122 at risk EG0036 affected116 at risk
Dry Mouth	Gastrointestinal disorders	EG0002 affected119 at risk EG0013 affected118 at risk EG00212 affected122 at risk EG003
Dyspepsia	Gastrointestinal disorders	EG0009 affected119 at risk EG0019 affected118 at risk EG0025 affected122 at risk EG003
Nausea	Gastrointestinal disorders	EG00013 affected119 at risk EG0019 affected118 at risk EG0026 affected122 at risk EG003
Salivary Hypersecretion	Gastrointestinal disorders	EG0002 affected119 at risk EG0018 affected118 at risk EG0021 affected122 at risk EG003
Tootache	Gastrointestinal disorders	EG0004 affected119 at risk EG0013 affected118 at risk EG00212 affected122 at risk EG003
Vomiting	Gastrointestinal disorders	EG0005 affected119 at risk EG00110 affected118 at risk EG0022 affected122 at risk EG003
Weight Increased	Investigations	EG0002 affected119 at risk EG0012 affected118 at risk EG00225 affected122 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	EG0006 affected119 at risk EG0011 affected118 at risk EG0022 affected122 at risk EG003
Increased Appetite	Metabolism and nutrition disorders	EG0001 affected119 at risk EG0013 affected118 at risk EG0027 affected122 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	EG0006 affected119 at risk EG0016 affected118 at risk EG0027 affected122 at risk EG003
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	EG0003 affected119 at risk EG0016 affected118 at risk EG0023 affected122 at risk EG003
Akathisia	Nervous system disorders	EG00014 affected119 at risk EG00127 affected118 at risk EG0029 affected122 at risk EG003
Dizziness	Nervous system disorders	EG0005 affected119 at risk EG0016 affected118 at risk EG0023 affected122 at risk EG003
Dystonia	Nervous system disorders	EG0004 affected119 at risk EG0019 affected118 at risk EG0021 affected122 at risk EG003
Headache	Nervous system disorders	EG00026 affected119 at risk EG00121 affected118 at risk EG00217 affected122 at risk EG003
Parkinsonism	Nervous system disorders	EG00011 affected119 at risk EG00113 affected118 at risk EG0026 affected122 at risk EG003
Sedation	Nervous system disorders	EG00011 affected119 at risk EG00116 affected118 at risk EG00217 affected122 at risk EG003
Somnolence	Nervous system disorders	EG00011 affected119 at risk EG00118 affected118 at risk EG00211 affected122 at risk EG003
Tremor	Nervous system disorders	EG0002 affected119 at risk EG0019 affected118 at risk EG0027 affected122 at risk EG003
Agitation	Psychiatric disorders	EG00013 affected119 at risk EG0017 affected118 at risk EG0028 affected122 at risk EG003
Anxiety	Psychiatric disorders	EG00012 affected119 at risk EG00112 affected118 at risk EG0027 affected122 at risk EG003
Insomnia	Psychiatric disorders	EG00015 affected119 at risk EG00114 affected118 at risk EG00213 affected122 at risk EG003
Psychotic Disorder	Psychiatric disorders	EG0002 affected119 at risk EG0010 affected118 at risk EG0023 affected122 at risk EG003
Restlessness	Psychiatric disorders	EG0006 affected119 at risk EG0014 affected118 at risk EG0024 affected122 at risk EG003

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D001569	Benzodiazepines
D001552	Benzazepines