Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Lurasidone, Schizophrenia, Latuda
Brief summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.
Interventions
DRUGLurasidone HCl
40 - 120mg per day
DRUGRisperidone
Risperidone
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: To be eligible to enter the study, each patient must comply with the following inclusion criteria: * Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment). * Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes. * Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study. * Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator. * Subject voluntarily agrees to participate in the study by giving written informed consent. Main
Exclusion criteria
To be excluded from entering this study if they fulfil any of the criteria below: * Subject has a chronic organic disease of the central nervous system (other than schizophrenia). * Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. * In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study. * Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events. | 12 months |
Countries
Argentina, Brazil, Chile, Croatia, Israel, South Africa, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day | 427 |
| Risperidone Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed | 202 |
| Total | 629 |
Baseline characteristics
| Characteristic | Lurasidone | Risperidone | Total |
|---|---|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 11.3 | 41.6 years STANDARD_DEVIATION 11.3 | 41.7 years STANDARD_DEVIATION 11.3 |
| Gender Female | 117 participants | 76 participants | 193 participants |
| Gender Male | 302 participants | 126 participants | 428 participants |
| Region of Enrollment Argentina | 24 participants | 13 participants | 37 participants |
| Region of Enrollment Brazil | 15 participants | 9 participants | 24 participants |
| Region of Enrollment Chile | 19 participants | 7 participants | 26 participants |
| Region of Enrollment Croatia | 7 participants | 5 participants | 12 participants |
| Region of Enrollment Israel | 3 participants | 0 participants | 3 participants |
| Region of Enrollment South Africa | 59 participants | 32 participants | 91 participants |
| Region of Enrollment Thailand | 13 participants | 3 participants | 16 participants |
| Region of Enrollment United States | 279 participants | 133 participants | 412 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 349 / 419 | 169 / 202 |
| serious Total, serious adverse events | 46 / 419 | 20 / 202 |
Outcome results
Primary
Number of Participants With Adverse Events.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lurasidone | Number of Participants With Adverse Events. | 395 participants |
| Risperidone | Number of Participants With Adverse Events. | 189 participants |