Aripiprazole in the Treatment of Bipolar Depression
This trial is active, not recruiting.
|Sponsor||Cambridge Health Alliance|
|Start date||April 2004|
|End date||March 2007|
|Trial size||20 participants|
|Trial identifier||NCT00226317, CHA-IRB-0030/01/04|
A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Male or female participants from 18 years up to 64 years old.
- DSM-IV diagnosis of bipolar disorder, any subtype; MADRS >16; MRS < 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control
- Current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations
|Official title||Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression|
|Principal investigator||Robert T Dunn, MD, PhD|
|Description||Study is 6 weeks long with 7 clinical visits.|
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