Status:
COMPLETED
A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression
Lead Sponsor:
Lindner Center of HOPE
Collaborating Sponsors:
University of Cincinnati
Conditions:
Bipolar Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The specific aim of this study is to obtain preliminary evidence of the acute effectiveness and tolerability of aripiprazole in the treatment of bipolar depression.
Eligibility Criteria
Inclusion
- subjects must have bipolar I, II or NOS disorder as defined by DSM-IV-TR; must have clinical significant depressive symptoms and have failed one or more mood stabilizer trials; may or may not be receiving antimanic or mood stabilizing medications; subjects or legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained; if female, subjects must be postmenopausal, surgically incapable of childbearing or practicing medically acceptable effective method(s) of contraception.
Exclusion
- subjects who do not have bipolar disorder by DSM-IV criteria; subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia or other cognitive disorders or a psychotic disorder; subjects with serious general medical illness; subjects who are allergic to or have demonstrated hypersensitivity to aripiprazole; women who are pregnant or nursing; subjects who have received an experimental drug or used an experimental device within 30 days; subjects who have a history of neurologic malignant syndrome.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00363337
Start Date
August 1 2006
End Date
March 1 2009
Last Update
June 22 2011
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559