Phase 3
N=817
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT00868959 ↗Enrolled (actual)
817
Serious AEs
2.9%
Results posted
Apr 2014
Primary outcome: Primary: Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment — 529 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- lurasidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sumitomo Pharma America, Inc.
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment |
529 | — |
| SECONDARY Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-4.4 | — |
| SECONDARY Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression) |
-0.58 | — |
Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
Eligibility 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, NCT#00868452 or Study D1050236, NCT#008668699.
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, NCT#00868452 or D1050236, NCT#008688699).
Data sourced from ClinicalTrials.gov (NCT00868959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.