Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

December 4, 2013 updated by: Kyooseob Ha, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Kyooseob Ha, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 14, 2009

First Submitted That Met QC Criteria

February 14, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 4, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-2008-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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