Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Bipolar Disorders, Metabolic Complication

Intervention / Treatment
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* Drug: aripiprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K |  | 0, 4, 8, 12, 18, 26 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG prolactin SAS BAS UKU-SERS-Pat-Korean version |  | 0, 4, 8, 12, 18, 26 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight gain, Bipolar disorder, metabolic complication, Aripiprazole, Clinical Trial, Antipsychotic, Metabolic syndrome, Psychopharmacology, Open Label