Text Size

Aripiprazole in the Treatment of Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Cambridge Health Alliance.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT00226317
First received: September 12, 2005
Last updated: June 17, 2008
Last verified: June 2008
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Depression state

Estimated Enrollment: 20
Study Start Date: April 2004
Estimated Study Completion Date: March 2007
Detailed Description:

Study is 6 weeks long with 7 clinical visits.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00226317     History of Changes
Other Study ID Numbers: CHA-IRB-0030/01/04
Study First Received: September 12, 2005
Last Updated: June 17, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aripiprazole
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013