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Completed

NCT Number: NCT01778244

Metformin for Treatment of Antipsychotic-induced Dyslipidemia

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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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Mental Health of The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

1000mg/day for 24 weeks

Primary outcomes

  1. low-density lipoprotein cholesterol

    Time frame: 8 weeks

Secondary outcomes

  1. high-density lipoprotein cholesterol

    Time frame: 8 weeks

  2. adverse effects

    Time frame: 8 weeks

Other outcomes

  1. body mass index

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

Metformin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind Study

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 29, 2013
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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