Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
- Registration Number
- NCT00845988
- Lead Sponsor
- Seoul National University Hospital
- 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 previous drugs to aripiprazole
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- 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 Criteria
- diagnosis of eating disorder, substance abuse, and psychotic disorder
- history of neurological and medical illness
- pregnant or breast feeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description switch to aripiprazole aripiprazole aripiprazole treatment as usual aripiprazole patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine
- Primary Outcome Measures
Name Time Method Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K 0, 4, 8, 12, 18, 26 week
- Secondary Outcome Measures
Name Time Method ECG prolactin SAS BAS UKU-SERS-Pat-Korean version 0, 4, 8, 12, 18, 26 week
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of