A 24-Week, Flexible-Dose, Open-label Extension Study of Lurasidone for the Treatment of Bipolar I Depressio

• Conditions: Bipolar I depression; MedDRA version: 9.1Level: LLTClassification code 10004936Term: Bipolar depression

• Registration Number: EUCTR2008-007483-42-DE
• Lead Sponsor: Sunovion Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-31
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 651

Inclusion Criteria

• Subject has agreed to participate by providing written informed consent
• Subject has completed 6 weeks of treatment in Study D1050235, D1050236 or
D1050292
• Subject is judged by the investigator to be suitable for participation in a clinical trial
involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Subject scores = 4 on MADRS item number 10 (suicidal thoughts) at baseline (Day 42 in Studies D1050235, D1050236 or D1050292)
• Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified