Status:
COMPLETED
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
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 diagnosed with bipolar I disorder, most resent episode depressed
- Subject must have a lifetime history of at least one bipolar manic or mixed episode
Exclusion
- History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
- Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
- Imminent risk of suicide or injury to self, others, or property
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT00868699
Start Date
April 1 2009
End Date
February 1 2012
Last Update
April 17 2014
Active Locations (55)
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1
Synergy Escondido,710 East Grand Ave.
Escondido, California, United States, 92025
2
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
Garden Grove, California, United States, 92645
3
Excell Research, Inc,3998 Vista Way,Suite 100
Oceanside, California, United States, 92056
4
University of California at Irvine Medical Center
Orange, California, United States, 92868