Metformin for Treatment of Antipsychotic-induced Dyslipidemia
- Registration Number
- NCT01778244
- Lead Sponsor
- Central South University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
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.
liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description metformin metformin metformin
- Primary Outcome Measures
Name Time Method low-density lipoprotein cholesterol 8 weeks
- Secondary Outcome Measures
Name Time Method high-density lipoprotein cholesterol 8 weeks adverse effects 8 weeks
Trial Locations
- Locations (1)
Institute of Mental Health of The Second Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China