drugset / Trial / NCT02751307

Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities

NCT02751307

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Metformin has been used for alleviating metabolic abnormalities in patients with schizophrenia. Until now, the lowest dose of metformin to treat metabolic abnormalities in clozapine-treated patients is 1000 mg/d. The aim of this study was to determine whether a lower dosage of metformin, such as 500 mg/d, is effective for improving metabolic profiles in clozapine-treated patients with pre-existing metabolic abnormalities. Methods: In this 12-week, randomized, double-blind, placebo-controlled trial, metformin 500 mg/d or 1000 mg/d or a placebo was prescribed to clozapine-treated patients with schizophrenia having pre-existing metabolic abnormalities. The recruited patients underwent physical and laboratory evaluations at week-4, week-8, and week-12.

Timeline

Start
2013-05
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 500 mg
Comparator Metformin Small molecule 1000 mg
Comparator Clozapine Other / unclassified 100 mg

Indications