Back to resultsStudy of Aripiprazole to Reduce Medical Risks in Bipolar Disorder
Primary Purpose
Bipolar Disorder, Metabolic Syndrome
Status
Terminated
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 focused on measuring bipolar disorder, sedation, overweight, Abilify, medication
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 65 years
- Body mass index (BMI) >=25;
- Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects;
- Able to give basic informed consent
- Meets DSM-IV criteria for lifetime bipolar I or II disorder and are presently in sustained remission (CGI BP<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.)
- Epworth Scale Score > 7
- Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study
Exclusion Criteria:
- Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
- Not competent to provide informed consent in the opinion of the investigator
- Ultra-rapid cycling (>4 episodes per month) bipolar I disorder
- Unstable and severe medical illness that requires immediate and intensive medical attention, When appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
- Women who are planning to become pregnant, currently pregnant, or breast-feeding;
- Current substance dependence; however, if a subject only has substance abuse/use, after the first positive drug screen, another drug screen will be repeated. If that drug screen is positive, the subject will be excluded. If the second drug screen is negative, the subject will be considered for the study;
- Subjects who have previously failed an adequate trial of aripiprazole.
- Subjects with a suicide attempt in the past 2 years;
- Subjects with a history of inpatient admission in the past 1 year;
- Subjects with a history of homicidal ideation;
- Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Aripiprazole
Outcomes
Primary Outcome Measures
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
Secondary Outcome Measures
Global Assessment of Functioning
Quality of Life Enjoyment Questionnaire
Young Mania Rating Scale
Hamilton Rating Scale for Depression
Full Information
NCT ID
NCT00665444
First Posted
April 21, 2008
Last Updated
October 19, 2017
Sponsor
University of Pittsburgh
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00665444
Brief Title
Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder
Official Title
Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated by the sponser due to low study enrollment.
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Metabolic Syndrome
Keywords
bipolar disorder, sedation, overweight, Abilify, medication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Aripiprazole
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.
Primary Outcome Measure Information:
Title
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
Time Frame
3 months
Title
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Global Assessment of Functioning
Time Frame
3 months
Title
Quality of Life Enjoyment Questionnaire
Time Frame
3 months
Title
Young Mania Rating Scale
Time Frame
3 months
Title
Hamilton Rating Scale for Depression
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 65 years
Body mass index (BMI) >=25;
Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects;
Able to give basic informed consent
Meets DSM-IV criteria for lifetime bipolar I or II disorder and are presently in sustained remission (CGI BP<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.)
Epworth Scale Score > 7
Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study
Exclusion Criteria:
Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
Not competent to provide informed consent in the opinion of the investigator
Ultra-rapid cycling (>4 episodes per month) bipolar I disorder
Unstable and severe medical illness that requires immediate and intensive medical attention, When appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
Women who are planning to become pregnant, currently pregnant, or breast-feeding;
Current substance dependence; however, if a subject only has substance abuse/use, after the first positive drug screen, another drug screen will be repeated. If that drug screen is positive, the subject will be excluded. If the second drug screen is negative, the subject will be considered for the study;
Subjects who have previously failed an adequate trial of aripiprazole.
Subjects with a suicide attempt in the past 2 years;
Subjects with a history of inpatient admission in the past 1 year;
Subjects with a history of homicidal ideation;
Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
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Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder
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