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Metformin Treatment on Cognitive Impairment of Schizophrenia

NCT ID: NCT05838573

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Participants screened through inclusion and exclusion criteria will be randomized to metformin or placebo group (2:1). The information of demographic data, medical history, previous and current medication regimen, and family history regarding psychotic and metabolic diseases will be collected at baseline. The assessments will be carried out at baseline, 12th week and 24th week, including physical examination, anthropometry, blood test(blood routine, liver function, renal function, blood lipids, fasting blood glucose, serum insulin and thyroid function), electrocardiogram, MRI scan( High-resolution T1-weighted Anatomical Images, Diffusion Tensor Imaging, Resting-state functional MRI and Arterial Spin Labeling) and psychiatry scales(Positive And Negative Syndrome Scale, Scale for Assessment of Negative Symptoms, Calgary Depressing Scale for Schizophrenia, Personal and Social Performance Scale, The Systematic Assessment for Treatment Emergent Events, the Simpson-Angus Extrapyramidal Side Effects Scale and the Barnes Akathisia Rating Scale); cognitive function will be assessed by the Measurement and Treatment Research to Improve Cognition in Schizophrenia(MATRICS) Consensus Cognitive Battery; biological samples also will be collected and stored to explore related mechanisms. Participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations. In addition, we will recruit healthy volunteers, and collect their demographic data, and family history regarding psychotic and metabolic diseases. 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.

Conditions

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Schizophrenia

Keywords

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Schizophrenia Cognitive impairment Metformin Clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups were observed longitudinally for 24 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metformin group

The goal is to investigate whether adding metformin will benefit the cognitive impairment in individuals with schizophrenia.

Group Type ACTIVE_COMPARATOR

Metformin treatment

Intervention Type DRUG

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.

Placebo group

The purpose of using placebo is to judge if the outcome is related to the study medication rather than other reasons.

Group Type PLACEBO_COMPARATOR

Placebo treatment

Intervention Type DRUG

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

Cross-sectional participants

Participants do not meet any 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.

the other inclusion criteria and exclusion criteria are same as the intervention group.

Group Type EXPERIMENTAL

Baseline assessments

Intervention Type OTHER

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

Healthy volunteer

Group Type EXPERIMENTAL

Volunteer assessments

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DRUG

Placebo treatment

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

Intervention Type DRUG

Baseline assessments

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male and female aged 18 to 50 years, who meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia.
2. Duration of illness less than 15 years with current symptoms in a stable condition.
3. 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.
4. Have great compliance with medication and follow-up.
5. 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.
6. Signed the study consent for participation.

Exclusion Criteria

1. Having a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders.
2. Having a history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system.
3. Taking antidepressants, stimulants, mood stabilizers or accepts electricity shock treatment.
4. Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed in an inpatient setting.
5. Taking dementia related drugs, minocycline, and other drugs that could affect cognitive function.
6. The routine blood tests showing significant abnormal renal, liver function or other somatic disease.
7. Pregnant or lactating women.

For schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong Mental Health Center

OTHER

Sponsor Role collaborator

The Second People's Hospital of Dali Bai Autonomous Prefecture

UNKNOWN

Sponsor Role collaborator

The Third people's Hospital of Jiangyin

UNKNOWN

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role lead

Responsible Party

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Renrong Wu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renrong Wu, M.D., Ph.D.

Role: STUDY_CHAIR

Mental Health Institute of Second Xiangya Hospital,CSU

Locations

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Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, China

Site Status RECRUITING

The Third Peoples's Hospital of Jiangyin

Jiangyin, Jiangsu, China

Site Status RECRUITING

Shandong Mental Health Center

Jinan, Shandong, China

Site Status RECRUITING

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Huang, M.D.

Role: CONTACT

Phone: 15874290980

Email: [email protected]

Jingmei Xiao, M.D.

Role: CONTACT

Phone: 17673129702

Email: [email protected]

Facility Contacts

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Renrong Wu, PhD, M.D

Role: primary

Jing Huang, MD

Role: backup

Jinjun Lu

Role: primary

Ranran Li, MD

Role: primary

Xuemei Li

Role: primary

Other Identifiers

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WU202211MET

Identifier Type: -

Identifier Source: org_study_id