Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Overview
- Phase
- Phase 4
- Intervention
- Metformin
- Conditions
- Schizophrenia
- Sponsor
- Seoul National University Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- change of weight
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Yong Min Ahn
professor
Seoul National University Hospital
Eligibility Criteria
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
Arms & Interventions
Metformin group
Metformin 500mg 1 tablet p.o. bid
Intervention: Metformin
Placebo group
1 tablet p.o. bid
Intervention: Placebo (for metformin)
Outcomes
Primary Outcomes
change of weight
Time Frame: 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 Outcomes
- Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)(baseline, 12 weeks, 24 weeks)
- World Health Organization Quality of Life-BREF (WHOQOL-BREF)(baseline, 12 weeks, 24 weeks)
- Positive and Negative Symptom Scale(PANSS)(baseline, 12 weeks, 24 weeks)
- MADRS(montgomery asberg depression rating scale)(baseline, 12 weeks, 24 weeks)
- Clinical Global Impression-severity(CGI-S)(baseline, 6 weeks, 24 weeks)
- Clinical Global Impression-improvement(CGI-I)(baseline, 12 weeks, 24 weeks)
- Beck's Depression Inventory(BDI)(baseline, 12 weeks, 24 weeks)
- Short form(36) Health survey (SF-36)(baseline, 12 weeks, 24 weeks)
- abdominal fat amount CT(baseline, 12 weeks, 24 weeks)
- change of prevalence of metabolic syndrome(baseline, 12 weeks, 24 weeks)