A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression
Phase 4
Completed
- Conditions
- Bipolar Depression
- Registration Number
- NCT00363337
- Lead Sponsor
- Lindner Center of HOPE
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Montgomery-Asberg Depression Rating Scale (MADRS) per protocol
- Secondary Outcome Measures
Name Time Method Clinical Global Impression Scale Modified for Bipolar Illness (CGI-BP) per protocol
Trial Locations
- Locations (1)
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States