drugset / Trial / NCT05838573

Metformin Treatment on Cognitive Impairment of Schizophrenia

NCT05838573 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

In this study, the investigators will investigate the effect and the underlying mechanism of metformin treatment on cognitive impairment in individuals with schizophrenia. The study will recruit 120 individuals with schizophrenia at 4 sites, who will be randomized to metformin or placebo group for 24-week treatment. Clinical assessments will be done at screen/baseline, 12th week and 24th week. Participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations. The specific aims are to compare healthy volunteers versus schizophrenic participants on:1) cognition; 2) MRI features, and to compare metformin group versus placebo group of 24-week treatment cohort on: 1) cognition; 2) clinical core symptoms; 3) MRI features. Biological samples also will be collected and stored to explore related mechanisms.

Timeline

Start
2023-05-08
Primary completion
2026-06-08
Completion
2026-06-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 500 mg Oral

Indications