NCT05838573CompletedPhase 3
Metformin Treatment on Cognitive Impairment of Schizophrenia
The Effect of Metformin Treatment on Cognitive Impairment in Individuals With Schizophrenia: A 24-week Multicentre Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 22 Mar 2023
- Start date
- 8 May 2023
- Primary completion date
- 8 Jun 2026
- Lead sponsor
- Central South University
- Diseases
- Schizophrenia
- NCT number
- NCT05838573
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 120
- From 8 May 2023 to the primary completion date, 8 Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders.
- Having a history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system.
- Taking dementia related drugs, minocycline, and other drugs that could affect cognitive function.
- The routine blood tests showing significant abnormal renal, liver function or other somatic disease.
- Pregnant or lactating women.
- For schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.
Other
- Taking antidepressants, stimulants, mood stabilizers or accepts electricity shock treatment.
- Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed in an inpatient setting.
Who the study is looking for
- Male and female aged 18 to 50 years, who meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia.
- Duration of illness less than 15 years with current symptoms in a stable condition.
- Participants must be receiving stable treatment with standard-of-care medications, with a maximum allowance of two antipsychotic medications. If additional anticholinergic agents are required for the management of extrapyramidal symptoms, they should be prescribed at low dosages.
- Have great compliance with medication and follow-up.
- Meet one of the diagnostic criteria for metabolic syndrome: 1)abdominal obesity (i.e. central obesity): waist circumference for male≥90 cm, for female ≥85 cm; 2)fasting blood glucose ≥110 mg/dl (6.1 mmol/l) and/or plasma glucose ≥140 mg/dl (7.8 mmol/l) after glucose load; 3)at fasting state, triglyceride ≥1.7 mmol/l; 4)at fasting state, HDL-C \<1.04 mmol/L.
- Signed the study consent for participation.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mental Health Institute of Second Xiangya Hospital,CSU Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Second People's Hospital of Dali Bai Autonomous Prefecture Coordinator of this site? Confirm its status | Dali | China | Unknown status |
| The Third Peoples's Hospital of Jiangyin Coordinator of this site? Confirm its status | Jiangyin | China | Unknown status |
| Shandong Mental Health Center Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.