The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
metformin 500mg p.o. bid for 24 weeks
placebo 1T bid
Seoul National University Hospital
Seoul, South Korea
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
Time frame: baseline, 12 weeks, 24 weeks
Positive and Negative Symptom Scale(PANSS)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Time frame: baseline, 12 weeks, 24 weeks
MADRS(montgomery asberg depression rating scale)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Time frame: baseline, 12 weeks, 24 weeks
Clinical Global Impression-severity(CGI-S)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Time frame: baseline, 6 weeks, 24 weeks
Clinical Global Impression-improvement(CGI-I)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Time frame: baseline, 12 weeks, 24 weeks
Beck's Depression Inventory(BDI)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Time frame: baseline, 12 weeks, 24 weeks
Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Time frame: 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)
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Time frame: baseline, 12 weeks, 24 weeks
Short form(36) Health survey (SF-36)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Time frame: baseline, 12 weeks, 24 weeks
abdominal fat amount CT
baseline, 12-week, 24-week
Time frame: baseline, 12 weeks, 24 weeks
change of prevalence of metabolic syndrome
waist circumference, blood pressure cholesterol,triglyceride, HDL-cholesterol,fasting glucose
Time frame: baseline, 12 weeks, 24 weeks