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Aripiprazole in the Treatment of Bipolar Depression

This study has been completed.
Bristol-Myers Squibb
Information provided by (Responsible Party):
Cambridge Health Alliance Identifier:
First received: September 12, 2005
Last updated: April 17, 2017
Last verified: April 2017
A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

Condition Intervention
Bipolar Disorder Drug: Aripiprazole

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression

Resource links provided by NLM:

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Depression state [ Time Frame: 6 week study ]

Enrollment: 20
Study Start Date: April 2004
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole in depression treatment Drug: Aripiprazole

Detailed Description:
Study is 6 weeks long with 7 clinical visits.

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00226317

United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
Bristol-Myers Squibb
Principal Investigator: Robert T Dunn, MD, PhD Cambridge Health Alliance
  More Information

Responsible Party: Cambridge Health Alliance Identifier: NCT00226317     History of Changes
Other Study ID Numbers: CHA-IRB-0030/01/04
Study First Received: September 12, 2005
Last Updated: April 17, 2017

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on June 23, 2017