Lurasidone HCL - A 6-week Phase 3 Study of Patients With... | NCT00790192

Status Module

Label	Type	Intervention Names
Lurasidone 80mg	Experimental	Drug: Lurasidone
Lurasidone 160mg	Experimental	Drug: Lurasidone
Quetiapine XR	Active Comparator	Drug: Quetiapine XR
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Lurasidone	Drug	Lurasidone 80 mg tablets	Lurasidone 80mg
Lurasidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase	The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.	Week 6

Secondary Outcomes

Measure	Description	Time Frame
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment	Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).	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

PubMed Identifier	Type	Citation	Retractions
23415311	Result	Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu C, Kalali AH, Pikalov A, Potkin SG. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 2013 Apr;145(1-3):101-9. doi: 10.1016/j.schres.2013.01.009. Epub 2013 Feb 13.
24035633

Results Section

Participant Flow Module

ID	Title	Description
FG000	Lurasidone 80 mg	Lurasidone 80 mg tablets taken orally once a day
FG001	Lurasidone 160 mg	Lurasidone 160 mg (4 tablets) taken orally once a day

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Lurasidone 80 mg	Lurasidone 80 mg tablets taken orally once a day
BG001	Lurasidone 160 mg	Lurasidone 160 mg (4 tablets) taken orally once a day
BG002	Quetiapine XR 600mg	Quetiapine XR 600 mg (4 tablets) orally taken once a day
BG003	Placebo	Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
BG004	Total	Total of all reporting groups

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
	BG00036.2± 10.9 BG00137.9± 11.3 BG00237.4± 10.4 BG003

Gender

There were two subjects, one randomized to the Quetiapine 600 mg group and one subject randomized to placebo that did not take study drug. Thus you see a discrepancy between the participant population and the overall baseline population for the two treatment groups (1 less patient in each treatment arm).

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00029 BG001

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00040 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

Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase

The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

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

Sep 2011

Least Squares Mean

95% Confidence Interval

scores on a scale

Week 6

ID	Title	Description
OG000	Lurasidone 80 mg	Lurasidone 80 mg tablets taken orally once a day
OG001	Lurasidone 160 mg	Lurasidone 160 mg (4 tablets) taken orally once a day
OG002	Quetiapine XR 600mg	Quetiapine XR 600 mg (4 tablets) orally taken once a day
OG003	Placebo	Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.

Units	Counts
Participants	OG000125 OG001121 OG002116 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-22.2(-25.7 to -18.7) OG001-26.5(-30.0 to -23.0) OG002-27.8(-31.3 to -24.2) 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 OG002 OG003		Mixed Models Analysis		<0.05						2-Sided	95						No	Superiority or Other

Secondary

Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment

Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).

Posted

Sep 2011

Least Squares Mean

95% Confidence Interval

scores on a scale

6-Weeks

ID	Title	Description
OG000	Lurasidone 80 mg	Lurasidone 80 mg tablets taken orally once a day
OG001	Lurasidone 160 mg	Lurasidone 160 mg (4 tablets) taken orally once a day
OG002	Quetiapine XR 600mg	Quetiapine XR 600 mg (4 tablets) orally taken once a day
OG003	Placebo	Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lurasidone 80 mg	Lurasidone 80 mg tablets taken orally once a day	1	125	71	125
EG001	Lurasidone 160 mg	Lurasidone 160 mg (4 tablets) taken orally once a day	4	121	76	121
EG002	Quetiapine XR 600mg	Quetiapine XR 600 mg (4 tablets) orally taken once a day	1	119	70	119
EG003	Placebo	Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.	4	121	69	121

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Left Ventricular Dysfunction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected125 at risk EG0014 events4 affected121 at risk EG0021 events1 affected119 at risk EG0034 events4 affected121 at risk
Abdominal Hernia Obstructive	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected125 at risk EG0011 events1 affected121 at risk EG0020 events0 affected119 at risk EG003
Non-cardiac Chest Pain	General disorders	Systematic Assessment	EG0000 events0 affected125 at risk EG0011 events1 affected121 at risk EG0020 events0 affected119 at risk EG003
Hepatitis Viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected125 at risk EG0010 events0 affected121 at risk EG002119 events1 affected119 at risk EG003
Hand Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected125 at risk EG0011 events1 affected121 at risk EG0020 events0 affected119 at risk EG003
Agression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected125 at risk EG0010 events0 affected121 at risk EG0020 events0 affected119 at risk EG003
Pyschotic Disorder	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected125 at risk EG0010 events0 affected121 at risk EG0021 events1 affected119 at risk EG003
Schizophrenia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected125 at risk EG0011 events1 affected121 at risk EG0020 events0 affected119 at risk EG003
Suicidal Behavior	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected125 at risk EG0010 events0 affected121 at risk EG0020 events0 affected119 at risk EG003
Suicidal Ideation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected125 at risk EG0010 events0 affected121 at risk EG0020 events0 affected119 at risk EG003
Physical Assault	Social circumstances	Systematic Assessment	EG0001 events1 affected125 at risk EG0010 events0 affected121 at risk EG0020 events0 affected119 at risk EG003
Labile Hypertension	Vascular disorders	Systematic Assessment	EG0000 events0 affected125 at risk EG0011 events1 affected121 at risk EG0020 events0 affected119 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected125 at risk EG0011 events1 affected121 at risk EG0028 events8 affected119 at risk EG0033 events3 affected121 at risk
Dry Mouth	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected125 at risk EG0012 events2 affected121 at risk EG0029 events9 affected119 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected125 at risk EG0017 events7 affected121 at risk EG0023 events3 affected119 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00010 events10 affected125 at risk EG0018 events8 affected121 at risk EG0024 events4 affected119 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0008 events8 affected125 at risk EG0019 events9 affected121 at risk EG0026 events6 affected119 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected125 at risk EG0011 events1 affected121 at risk EG0026 events6 affected119 at risk EG003
Weight Increase	Investigations	Systematic Assessment	EG0001 events1 affected125 at risk EG0012 events2 affected121 at risk EG0028 events8 affected119 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected125 at risk EG0011 events1 affected121 at risk EG0027 events7 affected119 at risk EG003
Akathisia	Nervous system disorders	Systematic Assessment	EG00010 events10 affected125 at risk EG0019 events9 affected121 at risk EG0022 events2 affected119 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0006 events6 affected125 at risk EG0017 events7 affected121 at risk EG00216 events16 affected119 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG00012 events12 affected125 at risk EG00112 events12 affected121 at risk EG00213 events13 affected119 at risk EG003
Parkinsonism	Nervous system disorders	Systematic Assessment	EG0007 events7 affected125 at risk EG0018 events8 affected121 at risk EG0024 events4 affected119 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0005 events5 affected125 at risk EG0018 events8 affected121 at risk EG00216 events16 affected119 at risk EG003
Agitation	Psychiatric disorders	Systematic Assessment	EG0004 events4 affected125 at risk EG0016 events6 affected121 at risk EG0023 events3 affected119 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0009 events9 affected125 at risk EG0014 events4 affected121 at risk EG0021 events1 affected119 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG00014 events14 affected125 at risk EG0018 events8 affected121 at risk EG0025 events5 affected119 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