Metformin for Treatment of Antipsychotic-induced Dyslipidemia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01778244

Enrollment

162

Registered

2013-01-29

Start date

2008-11-30

Completion date

2012-06-30

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

schizophrenia; dyslipidemia

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.

Interventions

DRUGmetformin

1000mg/day for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
low-density lipoprotein cholesterol	8 weeks

Secondary

Measure	Time frame
high-density lipoprotein cholesterol	8 weeks
adverse effects	8 weeks

Other

Measure	Time frame
body mass index	8 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026