Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Metabolic Syndrome
Intervention: Aripiprazole (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of Pittsburgh
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.
Clinical Details
Official title: Reducing Medical Risks in Individuals With Bipolar Disorder: Enhancing Outcomes With Aripiprazole
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: BodyMedia armband (sleep/wake and activity/inactivity patterns),Epworth Sleepiness Scale (general level of daytime sleepiness)
Secondary outcome: Global Assessment of functioningQuality of Life Enjoyment Questionnaire Young Mania Rating Scale Hamilton Rating Scale for Depression
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Starting date: April 2008
Last updated: February 17, 2011
|