Metformin Treatment on Cognitive Impairment of Schizophrenia

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.

Conditions

• Schizophrenia

Interventions

DRUG

Metformin treatment

Participants assigned to the metformin group will receive 500mg metformin three times daily (tid) for 24 weeks. The initial dose will be 500 mg orally in the evening for the first two days, followed by an increase to 500mg twice a day for the subsequent two days. By day 5, the dosage will be further increased to 500mg tid. The highest tolerated dosage will be maintained for participants who could not tolerate the maximum dosage.

DRUG

Placebo treatment

Parallel-dose adjustments will be made for the placebo group to maintain consistency in dosing between the two groups.

OTHER

Baseline assessments

Schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.

OTHER

Volunteer assessments

Apart from psychiatry scales(Hamilton Depression Scale, Young Mania Rating Scale and Self-reporting Inventory-90), other assessments for the healthy subjects are the same as the baseline for sczhiophrenic participants.

Sponsors & Collaborators

• Shandong Mental Health Center

  collaborator OTHER

• The Second People's Hospital of Dali Bai Autonomous Prefecture

  collaborator UNKNOWN

• The Third people's Hospital of Jiangyin

  collaborator UNKNOWN

• Central South University

  lead OTHER

Principal Investigators

• Renrong Wu, M.D., Ph.D. · Mental Health Institute of Second Xiangya Hospital,CSU

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-08

Primary Completion

2026-12-12

Completion

2027-06-30

Countries

• China

Study Locations