Phase 3
N=629
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00641745 ↗Enrolled (actual)
629
Serious AEs
10.6%
Results posted
Oct 2011
Primary outcome: Primary: Number of Participants With Adverse Events. — 395; 189 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lurasidone HCl (Drug); Risperidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events. |
395; 189 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00641745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.