NCT00226317CompletedNot Applicable
Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cambridge Health Alliance
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Depression state
Study Overview
Brief Summary
A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.
Detailed Description
Study is 6 weeks long with 7 clinical visits.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Aripiprazole in depression treatment
Experimental
Intervention: Aripiprazole (Drug)
Outcomes
Primary Outcomes
Depression state
Time Frame: 6 week study
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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