A Phase III study of SM-13496 in patients with schizophrenia
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080223187
- Lead Sponsor
- Sunovion Pharmaceuticals Inc.,
- Brief Summary
Subjects treated with lurasidone 40 mg/day experienced clinically meaningful and statistically significant improvements in the primary and secondary efficacy endpoints. Efficacy results in the overall population were consistent with those observed in Japanese subjects. Overall, and in Japanese subjects, lurasidone 40 mg was generally safe and well tolerated. Safety findings in this study were consistent with the well-known and established safety profile of lurasidone in adult subjects with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 483
Patients meets DSM-IV TR criteria for schizophrenia.
-Patients understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study etc.
-Patients has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
-Patient has Parkinson's disease.
-Patient has a history or complication of malignancy etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method