Confirmatory Study of SM-13496 (lurasidone HCl) in Patients with Schizophrenia
Phase 3
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080220563
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 460
Inclusion Criteria
- Patient meets DSM-IV criteria for schizophrenia.
- Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.
- Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.
etc.
Exclusion Criteria
- Patient 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 Change from baseline in PANSS total score
- Secondary Outcome Measures
Name Time Method