Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

NCT00665444 | Terminated Results

• 1 other identifier: BMS.WPIC.I#0008449
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),

  3 months

• Epworth Sleepiness Scale (General Level of Daytime Sleepiness)

  3 month

Secondary Outcomes (4)

• Global Assessment of Functioning

  3 months

• Quality of Life Enjoyment Questionnaire

  3 months

• Young Mania Rating Scale

  3 months

• Hamilton Rating Scale for Depression

  3 months

Study Arms (1)

A

EXPERIMENTAL

Aripiprazole

Drug: Aripiprazole

Interventions

Aripiprazole 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.

Also known as: Abilify

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Metabolic Syndrome; Overweight

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

the study was terminated early by the study sponsor due to low enrol...

Results Point of Contact

• Title: Holly Swartz, MD
• Organization: University of Pittsburgh

swartzha@upmc.edu

412-246-5588

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 22, 2017
• Results First Posted: February 12, 2016

Record last verified: 2017-10

Locations

US (1)