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Metformin for Treatment of Antipsychotic-induced Dyslipidemia

C

Central South University

Status and phase

Completed
Phase 4

Conditions

Dyslipidemia

Treatments

Drug: metformin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

162 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

162 participants in 2 patient groups, including a placebo group

metformin
Experimental group
Description:
metformin
Treatment:
Drug: metformin
placebo
Placebo Comparator group
Description:
placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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