Metformin for Treatment of Antipsychotic-induced Dyslipidemia
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidemia |
Drug: metformin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Metformin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind Study |
- low-density lipoprotein cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- high-density lipoprotein cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- adverse effects [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- body mass index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 162 |
| Study Start Date: | November 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: metformin
metformin
|
Drug: metformin
1000mg/day for 24 weeks
Other Name: metformin
|
|
Placebo Comparator: placebo
placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China, Hunan | |
| Institute of Mental Health of The Second Xiangya Hospital, Central South University | |
| Changsha, Hunan, China, 410011 | |
| Principal Investigator: | Renrong Wu, MD | Central South University |
More Information
No publications provided
| Responsible Party: | Jingping Zhao, professor, Central South University |
| ClinicalTrials.gov Identifier: | NCT01778244 History of Changes |
| Other Study ID Numbers: | RRWu |
| Study First Received: | January 19, 2013 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Central South University:
|
schizophrenia; dyslipidemia |
Additional relevant MeSH terms:
|
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Metformin Antipsychotic Agents Hypoglycemic Agents Physiological Effects of Drugs |
Pharmacologic Actions Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013