Back to resultsAripiprazole in the Treatment of Bipolar Depression
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility 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
Sites / Locations
- Cambridge Health Alliance
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aripiprazole in depression treatment
Arm Description
Outcomes
Primary Outcome Measures
Depression state
Secondary Outcome Measures
Full Information
NCT ID
NCT00226317
First Posted
September 12, 2005
Last Updated
April 17, 2017
Sponsor
Cambridge Health Alliance
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00226317
Brief Title
Aripiprazole in the Treatment of Bipolar Depression
Official Title
Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Study is 6 weeks long with 7 clinical visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aripiprazole in depression treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Depression state
Time Frame
6 week study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Dunn, MD, PhD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Aripiprazole in the Treatment of Bipolar Depression
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