Status:
COMPLETED
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
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 when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I...
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
- Subject must be taking lithium or divalproex at least 28 days prior to screening
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 :
January 1 2012
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT00868452
Start Date
April 1 2009
End Date
January 1 2012
Last Update
April 17 2014
Active Locations (71)
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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
Synergy Escondido
Escondido, California, United States, 92025