Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

This study has been completed.
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by (Responsible Party):
Kyooseob Ha, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00845988
First received: February 14, 2009
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Bipolar Disorders
Metabolic Complication
Drug: aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders Having Drug-induced Weight Gain

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K [ Time Frame: 0, 4, 8, 12, 18, 26 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ECG prolactin SAS BAS UKU-SERS-Pat-Korean version [ Time Frame: 0, 4, 8, 12, 18, 26 week ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: December 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845988

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
Principal Investigator: Kyooseob Ha, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Kyooseob Ha, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00845988     History of Changes
Other Study ID Numbers: 06-2008-104
Study First Received: February 14, 2009
Last Updated: December 4, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Bipolar disorder
metabolic complication
Aripiprazole
Weight gain
Clinical Trial
Antipsychotic
Metabolic syndrome
Psychopharmacology
Open Label

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014