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Failure to recruit the planned number of participants
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| Name | Class |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin group | Experimental | Metformin 500mg 1 tablet p.o. bid |
|
| Placebo group | Placebo Comparator | 1 tablet p.o. bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | metformin 500mg p.o. bid for 24 weeks |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Min Ahn, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Label | URL |
|---|---|
| study site | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo (for metformin) | Drug | placebo 1T bid |
|
|
| 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 |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |