Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bipolar Disorder Metabolic Syndrome |
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: | Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole |
- BodyMedia armband (sleep/wake and activity/inactivity patterns), [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Epworth Sleepiness Scale (general level of daytime sleepiness) [ Time Frame: 3 month ] [ Designated as safety issue: No ]
- Global Assessment of functioning [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Quality of Life Enjoyment Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Young Mania Rating Scale [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Hamilton Rating Scale for Depression [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 3 |
| Study Start Date: | April 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Aripiprazole
|
Drug: Aripiprazole
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.
Other Name: Abilify
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Holly Swartz, M.D., University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00665444 History of Changes |
| Other Study ID Numbers: | BMS.WPIC.I#0008449 |
| Study First Received: | April 21, 2008 |
| Last Updated: | February 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
bipolar disorder sedation overweight Abilify medication |
Additional relevant MeSH terms:
|
Bipolar Disorder Metabolic Syndrome X Affective Disorders, Psychotic Mood Disorders Mental Disorders Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
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 May 22, 2013