Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

NCT ID: NCT00665444

Last Updated: 2017-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-08-31

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.

Conditions

Bipolar Disorder; Metabolic Syndrome

Keywords

bipolar disorder; sedation; overweight; Abilify; medication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Aripiprazole

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Abilify

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 65 years

2. Body mass index (BMI) >=25;

3. Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects;

4. Able to give basic informed consent

5. 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.)

6. Epworth Scale Score > 7

7. Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study

Exclusion Criteria

1. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)

2. Not competent to provide informed consent in the opinion of the investigator

3. Ultra-rapid cycling (>4 episodes per month) bipolar I disorder

4. 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

5. Women who are planning to become pregnant, currently pregnant, or breast-feeding;

6. 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;

7. Subjects who have previously failed an adequate trial of aripiprazole.

8. Subjects with a suicide attempt in the past 2 years;

9. Subjects with a history of inpatient admission in the past 1 year;

10. Subjects with a history of homicidal ideation;

11. Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Holly Swartz

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

BMS.WPIC.I#0008449

Identifier Type: -

Identifier Source: org_study_id