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Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder
This study is currently recruiting participants.
Verified by University of Pittsburgh, October 2008
Sponsors and Collaborators: University of Pittsburgh
Bristol-Myers Squibb
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00665444
  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

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Aripiprazole BaseLine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole

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 ]

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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.

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

Contacts
Contact: Joan Buttenfield, RN 412-246-5566 ButtenfieldJA@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Bristol-Myers Squibb
  More Information

Responsible Party: University of Pittsburgh ( Holly Swartz, M.D. )
Study ID Numbers: BMS.WPIC.I#0008449
Study First Received: April 21, 2008
Last Updated: October 7, 2008
ClinicalTrials.gov Identifier: NCT00665444  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
bipolar disorder
sedation
overweight
Abilify
medication

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Overweight
Aripiprazole

Additional relevant MeSH terms:
Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009