The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

Phase 4

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Placebo (for metformin); Drug: Metformin

• Registration Number: NCT01654640
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.

Detailed Description

In this study, the investigators are going to examine the effect of metformin on obesity and metabolic disturbance in patients with schizophrenia who have taken clozapine.The metformin 500mg will be administrated per oral twice a day for 24 weeks and for control group, placebo will be given same route and process.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-08-01
• Study Start: 2012-09
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age: 18 ~ 65
• Patient with schizophrenia according to DSM-IV criteria
• Patient have signed on the informed consent, and well understood the objective and procedure of this study.
• Patient taking clozapine 3months or more
• Patient increased in weight more than 10 % of that of before antipsychotics use

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Exclusion Criteria

• Patient taking other antipsychotics with clozapine
• Patient in treatment of diabetes
• Patient in treatment of dyslipidemia
• Allergy or hypersensitivity to metformin
• Pregnant or breast-feeding female patient.
• Patient with severe medical condition

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo (for metformin)	1 tablet p.o. bid
Metformin group	Metformin	Metformin 500mg 1 tablet p.o. bid

Primary Outcome Measures

Name	Time	Method
change of weight	baseline, 12 weeks, 24 weeks	change of weight after 12-week, 24-week. calculation; (weight of 12-week - weight of baseline)/baseline weight (weight of 24-week - weight of baseline)/baseline weight

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-severity(CGI-S)	baseline, 6 weeks, 24 weeks	baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Clinical Global Impression-improvement(CGI-I)	baseline, 12 weeks, 24 weeks	baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Positive and Negative Symptom Scale(PANSS)	baseline, 12 weeks, 24 weeks	baseline, 1-week, 4-week, 12-week, 24-week(end-point)
MADRS(montgomery asberg depression rating scale)	baseline, 12 weeks, 24 weeks	baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Beck's Depression Inventory(BDI)	baseline, 12 weeks, 24 weeks	baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)	baseline, 12 weeks, 24 weeks	baseline, 1-week, 4-week, 12-week, 24-week(end-point)
World Health Organization Quality of Life-BREF (WHOQOL-BREF)	baseline, 12 weeks, 24 weeks	baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Short form(36) Health survey (SF-36)	baseline, 12 weeks, 24 weeks	baseline, 1-week, 4-week, 12-week, 24-week(end-point)
abdominal fat amount CT	baseline, 12 weeks, 24 weeks	baseline, 12-week, 24-week
change of prevalence of metabolic syndrome	baseline, 12 weeks, 24 weeks	waist circumference, blood pressure cholesterol,triglyceride, HDL-cholesterol,fasting glucose

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of