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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
Time frame: 3 months
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
Time frame: 3 month
Global Assessment of Functioning
Time frame: 3 months
Quality of Life Enjoyment Questionnaire
Time frame: 3 months
Young Mania Rating Scale
Time frame: 3 months
Hamilton Rating Scale for Depression
Time frame: 3 months
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