Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

This study has been terminated.
(The study was terminated by the sponser due to low study enrollment.)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00665444
First received: April 21, 2008
Last updated: February 17, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665444

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Bristol-Myers Squibb
  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 July 28, 2014