Metformin for Treatment of Antipsychotic-induced Dyslipidemia
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Dyslipidemia |
Intervention | Drug: metformin |
Phase | Phase 4 |
Sponsor | Central South University |
Responsible Party | Central South University |
ClinicalTrials.gov Identifier | NCT01778244 |
First Received | January 19, 2013 |
Last Updated | January 25, 2013 |
Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 19, 2013 |
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Last Updated Date | January 25, 2013 |
Start Date | November 2008 |
Estimated Primary Completion Date | June 2012 |
Current Primary Outcome Measures | low-density lipoprotein cholesterol [Time Frame: 8 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Metformin for Treatment of Antipsychotic-induced Dyslipidemia |
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Official Title | Metformin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind Study |
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. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Dyslipidemia |
Intervention | Drug: metformin 1000mg/day for 24 weeks Other Names: metformin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 162 |
Estimated Completion Date | June 2012 |
Estimated Primary Completion Date | December 2011 |
Eligibility Criteria | 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. - Exclusion Criteria: liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01778244 |
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Other Study ID Numbers | RRWu |
Has Data Monitoring Committee | Yes |
Information Provided By | Central South University |
Study Sponsor | Central South University |
Collaborators | Not Provided |
Investigators | Principal Investigator: Renrong Wu, MD Central South University |
Verification Date | January 2013 |
Locations[ + expand ][ + ]
Institute of Mental Health of The Second Xiangya Hospital, Central South University | Changsha, Hunan, China, 410011 |
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