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Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00665444
Recruitment Status : Terminated (The study was terminated by the sponser due to low study enrollment.)
First Posted : April 23, 2008
Results First Posted : February 12, 2016
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Bipolar Disorder Metabolic Syndrome Drug: Aripiprazole

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole
Study Start Date : April 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009


Arms and Interventions

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 Name: Abilify


Outcome Measures

Primary Outcome Measures :
  1. BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns), [ Time Frame: 3 months ]
  2. Epworth Sleepiness Scale (General Level of Daytime Sleepiness) [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. Global Assessment of Functioning [ Time Frame: 3 months ]
  2. Quality of Life Enjoyment Questionnaire [ Time Frame: 3 months ]
  3. Young Mania Rating Scale [ Time Frame: 3 months ]
  4. Hamilton Rating Scale for Depression [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Holly Swartz, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00665444     History of Changes
Other Study ID Numbers: BMS.WPIC.I#0008449
First Posted: April 23, 2008    Key Record Dates
Results First Posted: February 12, 2016
Last Update Posted: November 22, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Disease
Metabolic Syndrome X
Bipolar Disorder
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bipolar and Related Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs