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Aripiprazole in the Treatment of Bipolar Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226317
First Posted: September 27, 2005
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Cambridge Health Alliance
  Purpose
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: None (Open Label)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226317


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

Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00226317     History of Changes
Other Study ID Numbers: CHA-IRB-0030/01/04
First Submitted: September 12, 2005
First Posted: September 27, 2005
Last Update Posted: April 18, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs