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Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

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ClinicalTrials.gov Identifier: NCT00845988
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : December 5, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : December 2008
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K [ Time Frame: 0, 4, 8, 12, 18, 26 week ]

Secondary Outcome Measures :
  1. ECG prolactin SAS BAS UKU-SERS-Pat-Korean version [ Time Frame: 0, 4, 8, 12, 18, 26 week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kyooseob Ha, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00845988     History of Changes
Other Study ID Numbers: 06-2008-104
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs