ong-term Extension Study of SM-13496 (lurasidone HCl) in Patients with Schizophrenia <Phase 3>
Phase 3
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080221817
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 435
Inclusion Criteria
Patients who are considered by the investigator eligible for the present study with no significant safety concerns
- Patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study
Exclusion Criteria
- Patients who are planning pregnancy for the expected duration of the study
- Patients who are otherwise considered ineligible for the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PANSS total Score<br>Change from baseline in PANSS total score
- Secondary Outcome Measures
Name Time Method Adverse Event<br>the proportion of subjects with Adverse Events (AEs), Discontinuations due to AEs, and Serious Adverse Events (SAEs).