Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole

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.

Study Overview

• Status: Terminated
• Conditions: Metabolic Syndrome; Bipolar Disorder
• Intervention / Treatment: Drug: Aripiprazole

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),	3 months
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)	3 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: April 21, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 23, 2008

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: overweight; medication; bipolar disorder; sedation; Abilify
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Bipolar and Related Disorders; Disease; Metabolic Syndrome; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: BMS.WPIC.I#0008449