Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00845988

Collaborator

Korea Otsuka Pharmaceutical Co., Ltd. (Industry)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorders Metabolic Complication	Drug: aripiprazole	Phase 4

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

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders Having Drug-induced Weight Gain

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: treatment as usual patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine	Drug: aripiprazole dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks
Experimental: switch to aripiprazole aripiprazole	Drug: aripiprazole dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks

Arm

Intervention/Treatment

Active Comparator: treatment as usual

patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine

Drug: aripiprazole

dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks

Experimental: switch to aripiprazole

aripiprazole

Drug: aripiprazole

dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks

Outcome Measures

Primary Outcome Measures

Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K [0, 4, 8, 12, 18, 26 week]

Secondary Outcome Measures

ECG prolactin SAS BAS UKU-SERS-Pat-Korean version [0, 4, 8, 12, 18, 26 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)