Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder
Status:
Terminated
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
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.