Skip to main content
OpenTrials
Completed

NCT Number: NCT00845988

Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Disorders Bipolar Disorder Bipolar and Related Disorders Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Complication Metabolic Diseases Metabolic Syndrome Mood Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole

Drug

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

Primary outcomes

  1. Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K

    Time frame: 0, 4, 8, 12, 18, 26 week

Secondary outcomes

  1. ECG prolactin SAS BAS UKU-SERS-Pat-Korean version

    Time frame: 0, 4, 8, 12, 18, 26 week

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 18, 2009
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.