Schizophrenia
Conditions
Keywords
schizophrenia, obesity, clozapine, metformin
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.
Interventions
DRUGMetformin
metformin 500mg p.o. bid for 24 weeks
DRUGPlacebo (for metformin)
placebo 1T bid
Sponsors
Daewoong Pharmaceutical Co. LTD.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| MADRS(montgomery asberg depression rating scale) | baseline, 12 weeks, 24 weeks | baseline, 1-week, 4-week, 12-week, 24-week(end-point) |
| 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) |
| Beck's Depression Inventory(BDI) | 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) |
| 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 |
| Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS) | baseline, 12 weeks, 24 weeks | baseline, 1-week, 4-week, 12-week, 24-week(end-point) |
Countries
South Korea
Outcome results
None listed