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Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome | Clinical Trials | Clareo Health

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Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome

NCT04518319•Shanghai Mental Health Center

View on ClinicalTrials.gov

Summary

This is a single-center, randomized, parallel-control study conducted in schizophrenic inpatients with metabolic syndrome who have been conducted with olanzapine. The purpose of this study is to evaluate the efficacy and safety of omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct current stimulation( tDCS). Following a screening period, subjects who meet the entry criteria will be randomized to treated with omega-3 polyunsaturated fatty acids1.2mg per day, Xbox aerobic exercise 30min per day and tDCS at 2mA, 20 min(5 session/week) for 12 weeks.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Meets the Diagnostic and Statistical Manual of Mental Disorder,Fifth Edition(DSM-V) criteria for Schizophrenia.
•2. Patients have got standard treatment of olanzapine monotherapy for more than 6 months, PANSS baseline ≤ 60.
•3. Meets the ATP-III criteria for metabolic syndrome.
•4. Male or female subjects aged 18-60 years, education level of junior high school for above.
•5. The patient fully understand and signed the informed consent form.

Exclusion Criteria

•1. Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
•2. Pregnant or lactating women and women of childbearing potential throughout the study period; patients who have plans to move to other places within the year.
•3. History of diabetes, hyperlipidemia and other metabolic abnormalities.
•4. Due to other reasons, the researchers considered it unsuitable to participate in this clinical trial.
•\-

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

October 1, 2020

Primary Completion Date

November 1, 2024

Completion Date

November 1, 2024

Last Updated

April 18, 2023

Enrollment

120

ESTIMATED participants

Conditions

Schizophrenia

Interventions

Omega-3 polyunsaturated fatty acids

DRUG

Xbox aerobic exercise

BEHAVIORAL

transcranial direct current stimulation,tDCS

DEVICE

Olanzapine

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

Inclusion Criteria

Exclusion Criteria

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