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NCT00845988 Clinical Trial

Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

Bipolar Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00845988
Other study ID # 06-2008-104
Secondary ID
Status Completed
Phase Phase 4
First received February 14, 2009
Last updated December 4, 2013
Start date December 2008
Est. completion date March 2012

Study information
Verified date December 2013
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K 0, 4, 8, 12, 18, 26 week Yes
Secondary ECG prolactin SAS BAS UKU-SERS-Pat-Korean version 0, 4, 8, 12, 18, 26 week Yes
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