Status:
COMPLETED
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Bipolar Disorders
Metabolic Complication
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
Detailed Description
* reduced treatment adherence due to metabolic side effects * suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers * randomized trial of switch from ...
Eligibility Criteria
Inclusion
- patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
- age between 18 and 65
- Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
- patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie \>7% weight gain)
Exclusion
- diagnosis of eating disorder, substance abuse, and psychotic disorder
- history of neurological and medical illness
- pregnant or breast feeding women
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00845988
Start Date
December 1 2008
End Date
March 1 2012
Last Update
December 5 2013
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707