A 12-week, Open-Label Extension Study of Lurasidone (SM-13496) in Subjects with Schizophrenia
- Conditions
- Schizophrenia
- Registration Number
- JPRN-jRCT2080223209
- Lead Sponsor
- Sunovion Pharmaceuticals Inc.,
- Brief Summary
The effectiveness data suggest that lurasidone treatment improves positive and negative symptoms of schizophrenia and global symptoms. In addition, there were no unexpected AEs or clinically significant changes in any of the safety parameters. Safety results of this study were consistent with the results from the core study (D1001066) and follow the known safety profile of lurasidone and other atypical antipsychotic drugs of the same class.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 289
Subject has completed the study D1001066 and has completed all required assessments on the final study visit.
- Subject 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 etc.
- Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, or others.
- Subject who are otherwise considered ineligible for the study by the investigator etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse events (AEs)<br>Frequency of AE or treatment-related AEs
- Secondary Outcome Measures
Name Time Method efficacy<br>PANSS total score<br>Change frome baseline in PANSS total score