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Aripiprazole in the Treatment of Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00226317
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Cambridge Health Alliance

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Aripiprazole Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : April 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aripiprazole in depression treatment Drug: Aripiprazole



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


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

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

Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT00226317     History of Changes
Other Study ID Numbers: CHA-IRB-0030/01/04
First Posted: September 27, 2005    Key Record Dates
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