Lurasidone HCl - A Long Term Phase 3 Study of Patients Wi... | NCT00789698

NCT00789698

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Lurasidone HC1	Experimental		Drug: Lurasidone HC1
Quetiapine	Active Comparator		Drug: Quetiapine XR

Name	Type	Description	Arm Group Labels	Other Names
Lurasidone HC1	Drug	Lurasidone 40-160 mg/day flexibly dosed.	Lurasidone HC1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relapse of Psychotic Symptoms	Time to relapse will be defined as the earliest occurrence of any of the following: Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3 rehospitalization for worsening of psychosis emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.	12 Months

Secondary Outcomes

Measure	Description	Time Frame
Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.	The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.

Eligibility Module

Contacts/Locations 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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23583011	Result	Loebel A, Cucchiaro J, Xu J, Sarma K, Pikalov A, Kane JM. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study. Schizophr Res. 2013 Jun;147(1):95-102. doi: 10.1016/j.schres.2013.03.013. Epub 2013 Apr 11.
24035633	Result	Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lurasidone 80mg	Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
FG001	Lurasidone 160 mg	Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Lurasidone 80mg	Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
BG001	Lurasidone 160 mg	Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
BG002	Placebo-Lurasidone	Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
BG003	Quetiapine-Quetiapine	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
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
	BG00036.6± 11.7 BG00137.6± 11.7 BG00237.5± 11.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG00127 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00018 BG00115 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Relapse of Psychotic Symptoms

Time to relapse will be defined as the earliest occurrence of any of the following:

Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3
rehospitalization for worsening of psychosis
emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.

The population for relapse analyses is the relapse population which consists of those subjects who are enrolled in the present study, demonstrated response to 6 weeks of treatment with either lurasidone or quetiapine XR in study D1050233-NCT 00790192, and who took at least one dose of study medication in the present study.

Posted

Number

participants

12 Months

ID	Title	Description
OG000	Lurasidone-Lurasidone	Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
OG001	Quetiapine-Quetiapine	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study

Units	Counts
Participants	OG000139 OG00179

Title

Denominators

Categories

Title	Measurements
	OG00029 OG00121(1 to 1)

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	Comparison of time to relapse of psychotic symptoms between LUR-LUR and QXR-QXR as analyzed using the Cox proportional-hazards model.	COX Proportional Hazards Model			There is no hypothesis tested. Since this was a non-inferiority study, the upper bound of the 95% CI for the hazard ratio was compared to the pre-specified margin of 1.93 to demonstrate the non-inferiority of lurasidone compared to Quetiapine XR.	Hazard Ratio (HR)	0.728			2-Sided	95	0.410	1.295				Yes	Non-Inferiority or Equivalence

Secondary

Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.

The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.

The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline and 6 Months

ID	Title	Description
OG000	Lurasidone-Lurasidone	Lurasidone 80 mg/day or Lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
OG001	Quetiapine-Quetiapine	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study

Secondary

Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)

The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline and 12 months

ID	Title	Description
OG000	Lurasidone-Lurasidone	Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
OG001	Quetiapine-Quetiapine	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study

Units	Counts
Participants

Secondary

Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores

The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline and 12 months

ID	Title	Description
OG000	Lurasidone-Lurasidone	Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
OG001	Quetiapine-Quetiapine	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lurasidone 80mg	Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.	9	72	44	72
EG001	Lurasidone 160 mg	Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.	6	79	51	79
EG002	Placebo-Lurasidone	Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study	2	56	35	56
EG003	Quetiapine-Quetiapine	Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study	17	85	53	85

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute Myocardial Infarction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected72 at risk EG0010 events0 affected79 at risk EG0020 events0 affected56 at risk EG0031 events1 affected85 at risk
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 events0 affected72 at risk EG0010 events0 affected79 at risk EG0020 events0 affected56 at risk EG003
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected72 at risk EG0010 events0 affected79 at risk EG0021 events1 affected56 at risk EG003
Lower Limb Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected79 at risk EG0020 events0 affected56 at risk EG003
Skeletal Injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected79 at risk EG0020 events0 affected56 at risk EG003
Parkinsonism	Nervous system disorders	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected79 at risk EG0020 events0 affected56 at risk EG003
Agitation	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected79 at risk EG0020 events0 affected56 at risk EG003
Completed Suicide	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected79 at risk EG0020 events0 affected56 at risk EG003
Psychotic Disorder	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected72 at risk EG0012 events2 affected79 at risk EG0020 events0 affected56 at risk EG003
Schizophrenia	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected72 at risk EG0011 events1 affected79 at risk EG0021 events1 affected56 at risk EG003
Schizophrenia, paranoid type	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected79 at risk EG0020 events0 affected56 at risk EG003
Suicidal Behavior	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected72 at risk EG0010 events0 affected79 at risk EG0020 events0 affected56 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected72 at risk EG0012 events2 affected79 at risk EG0024 events4 affected56 at risk EG0034 events4 affected85 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected72 at risk EG0014 events4 affected79 at risk EG0026 events6 affected56 at risk EG003
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected72 at risk EG0011 events1 affected79 at risk EG0023 events3 affected56 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0008 events3 affected72 at risk EG0014 events3 affected79 at risk EG0024 events3 affected56 at risk EG003
Weight Increased	Investigations	Systematic Assessment	EG0006 events3 affected72 at risk EG0016 events6 affected79 at risk EG0021 events1 affected56 at risk EG003
Akathisia	Nervous system disorders	Systematic Assessment	EG00016 events11 affected72 at risk EG0019 events8 affected79 at risk EG0029 events6 affected56 at risk EG003
Dystonia	Nervous system disorders	Systematic Assessment	EG0007 events4 affected72 at risk EG0011 events1 affected79 at risk EG0026 events2 affected56 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0007 events5 affected72 at risk EG00116 events11 affected79 at risk EG0025 events3 affected56 at risk EG003
Parkinsonism	Nervous system disorders	Systematic Assessment	EG0005 events3 affected72 at risk EG0017 events6 affected79 at risk EG00212 events9 affected56 at risk EG003
Somnolence	Nervous system disorders	Systematic Assessment	EG0001 events1 affected72 at risk EG0014 events4 affected79 at risk EG0021 events1 affected56 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected72 at risk EG0016 events6 affected79 at risk EG0023 events2 affected56 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0005 events5 affected72 at risk EG0018 events7 affected79 at risk EG0024 events4 affected56 at risk EG003
Schizophrenia	Psychiatric disorders	Systematic Assessment	EG0006 events5 affected72 at risk EG0012 events2 affected79 at risk EG0022 events2 affected56 at risk EG003

ID	Term
D012559	Schizophrenia

This is a non-inferiority analysis. Lurasidone will be declared as effective as quetiapine XR in preventing relapse if the upper bound of a 2-sided 95% confidence limit for the hazard ration of lurasidone vs. quetiapine is no greater than an equivalence hazard ratio margin of 1.93.

Units	Counts
Participants	OG00086 OG00141

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