Status:
COMPLETED
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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
- 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
- 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).
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
817 Patients enrolled
Trial Details
Trial ID
NCT00868959
Start Date
April 1 2009
End Date
February 1 2013
Last Update
April 14 2016
Active Locations (151)
Enter a location and click search to find clinical trials sorted by distance.
1
Woodland International Research Inc
Little Rock, Arkansas, United States, 72211
2
South Coast Clinical Trials Inc.
Anaheim, California, United States, 92804
3
Catalina Research Institute
Chino, California, United States, 91710
4
Clinical Innovations Inc.
Costa Mesa, California, United States, 92626