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

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

Detailed Description
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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.

Official Title
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Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Metformin
* Drug: Placebo (for metformin)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin group<br>Metformin 500mg 1 tablet p.o. bid | Drug: Metformin<br>* metformin 500mg p.o. bid for 24 weeks<br>* Other names: Diabex;|
| Placebo Comparator: Placebo group<br>1 tablet p.o. bid | Drug: Placebo (for metformin)<br>* placebo 1T bid<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of weight | 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 | baseline, 12 weeks, 24 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, obesity, clozapine, metformin