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NCT00226317 Clinical Trial

Aripiprazole in the Treatment of Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:
Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00226317
Other study ID # CHA-IRB-0030/01/04
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated April 17, 2017
Start date April 2004
Est. completion date February 2008

Study information
Verified date April 2017
Source Cambridge Health Alliance
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

Description:

Study is 6 weeks long with 7 clinical visits.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 2008
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aripiprazole

Locations
Country Name City State
United States Cambridge Health Alliance Cambridge Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Cambridge Health Alliance Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Depression state 6 week study
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