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Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Metformin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of metformin for antipsychotic-induced dyslipidemia.
The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.162 patients were randomized to one of two 24-week individual treatments: metformin (1000mg/day)or placebo. Medications were provided in double-blind fashion.The assessments include lipid levels, body weight, body mass index, fasting glucose, fasting insulin and insulin resistance index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Experimental | metformin |
|
| placebo | Placebo Comparator | placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | 1000mg/day for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| low-density lipoprotein cholesterol | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| high-density lipoprotein cholesterol | 8 weeks | |
| adverse effects | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| body mass index | 8 weeks |
Inclusion Criteria:
Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.
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Exclusion Criteria:
liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Renrong Wu, MD | Second Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Mental Health of The Second Xiangya Hospital, Central South University | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| D001523 | Mental Disorders |