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CompletedNCT01778244Updated Jan 29, 2013

Metformin for Treatment of Antipsychotic-induced Dyslipidemia

A Phase 4 interventional study of metformin in Dyslipidemia, sponsored by Central South University. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-01-29.

Sponsored by Central South University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dyslipidemia

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Keywords

  • schizophrenia; dyslipidemia
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 162 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
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

-

Exclusion Criteria:

liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
162 participants (actual)

Study arms

  • Experimental
    metformin

    metformin

    Drug: metformin

  • Placebo comparator
    placebo

    placebo

Interventions

  • Drugmetformin

    1000mg/day for 24 weeks

06

What researchers measure

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

07

Study locations

1 site
  • Institute of Mental Health of The Second Xiangya Hospital, Central South University
    Changsha, Hunan 410011, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01778244
Lead sponsor
Central South University
Responsible party
Jingping Zhao (professor, Central South University) — Principal investigator
First posted
Jan 29, 2013
Start date
Nov 2008
Primary completion
Dec 2011
Completion
Jun 2012
Last update
Jan 29, 2013

Study contacts

Renrong Wu, MD
principal investigator · Central South University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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