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Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

NCT ID: NCT00845988

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-03-31

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

Conditions

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Bipolar Disorders Metabolic Complication

Keywords

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Bipolar disorder metabolic complication Aripiprazole Weight gain Clinical Trial Antipsychotic Metabolic syndrome Psychopharmacology Open Label

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment as usual

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

Group Type ACTIVE_COMPARATOR

aripiprazole

Intervention Type DRUG

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

switch to aripiprazole

aripiprazole

Group Type EXPERIMENTAL

aripiprazole

Intervention Type DRUG

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

Interventions

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aripiprazole

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyooseob Ha

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyooseob Ha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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06-2008-104

Identifier Type: -

Identifier Source: org_study_id