urasidone - A 24-week Extension Study of Patients With Bipolar I Depressio
Phase 3
Completed
- Conditions
- Health Condition 1: null- Bipolar I depressionHealth Condition 2: F318- Other bipolar disorders
- Registration Number
- CTRI/2009/091/000752
- Lead Sponsor
- Sunovion Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 460
Inclusion Criteria
Subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment
Subject has completed the 6-week treatment period and all required assessments on the final study visit (Day 42, Visit 8) of either Study D1050235 or Study D1050236
Exclusion Criteria
Imminent risk of suicide, injury to self or to others, or damage to property
Subject has evidence of severe movement disorders.
Subject tests positive for drugs of abuse (at Visit 8 in Study D1050235 or D1050236)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of lurasidone in subjects, who have completed (ie, reached 6-week endpoint) of Study D1050235 or Study D1050236Timepoint: 6 week
- Secondary Outcome Measures
Name Time Method Mean change from baseline to endpoint (Week 24) in: The secondary objectives of the study are as follows: [ Time Frame: 24 weeks ] <br/ ><br>Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 24 weeks ] <br/ ><br>Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) [ Time Frame: 24 weeks ] <br/ ><br>Timepoint: Time Frame: 24 weeks