Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder



Status:Terminated
Conditions:Psychiatric, Endocrine, Bipolar Disorder
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:11/24/2017
Start Date:April 2008
End Date:August 2009

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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.


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.
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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