Health Condition 1: null- Bipolar I depression Health Condition 2: F318- Other bipolar disorders
Conditions
Interventions
Intervention1: lurasidone: Lurasidone 20, 40, 60, 80, 100 or 120
mg/day, orally, once daily in the evening, with a meal or within 30 minutes after eating, for 6 weeks.
Lurasidone dosing will be initia
Sponsors
Sunovion Pharmaceuticals Inc
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of lurasidone in subjects, who have completed (ie, reached 6-week endpoint) of Study D1050235 or Study D1050236Timepoint: 6 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to endpoint (Week 24) in: The secondary objectives of the study are as follows: [ Time Frame: 24 weeks ] Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 24 weeks ] Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) [ Time Frame: 24 weeks ] Timepoint: Time Frame: 24 weeks | — |
Countries
Czech Republic, France, Germany, India, Poland, Romania, Russian Federation, South Africa, Ukraine, United States of America
Contacts
Public ContactSuchela Srivatsa
IQVIA RDS (India) Private Limited
Outcome results
None listed