Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

April 14, 2023 updated by: Yan CHEN, Shanghai Mental Health Center

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: omega-3 polyunsaturated fatty acids
Patients randomized to the omega-3 polyunsaturated fatty acids will receive treatment with 1200mg per day plus on-going olanzapine.
Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.
Experimental: Xbox aerobic exercise
Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine.
Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.
Experimental: transcranial direct current stimulation
Patients randomized to the transcranial direct current stimulation will be applied for transcranial direct current stimulation 5 session/week at 2mA, 20min plus on-going olanzapine. The anodal electrode will be placed over the left dorsolateral prefrontal cortex.
Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.
Experimental: olanzapine
Patients randomized to the olanzapine will receive conventional treatment-olanzapine.
Patients will take only olanzapine pills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
Time Frame: from baseline to 3 months after treatment
Change in the the MATRICS consensus cognitive battery between randomization
from baseline to 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the Schizophrenia Quality of Life Scale(SQLS)
Time Frame: assessed from baseline to 3 months after treatment
The aim is to explore what kind of intervention will improve the quality of life as measured with the Schizophrenia Quality of Life Scale(SQLS). The scores between 1-100. The lower scores means a better outcome.
assessed from baseline to 3 months after treatment
change in the scale of social function in psychosis inpatients
Time Frame: assessed from baseline to 3 months after treatment
The aim is to explore what kind of intervention will improve the patients' social function as measured with the scale of social function in psychosis inpatients(SSPI).<18 points means severe defects, 18-28 points means moderate defects, 29-38 means mild defects. The higher scores means a better outcome.
assessed from baseline to 3 months after treatment
metabolic indicators
Time Frame: assessed from baseline to week 24
Height(kilograms) and weight(meters) will be measured to evaluate the patients' BMI(kg/m2) at baseline, week4,12,16(1months after treatment ) and 24(3 months after treatment).
assessed from baseline to week 24
biological index
Time Frame: assessed from baseline to week 24
CRP(mg/dl) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
assessed from baseline to week 24
biological index
Time Frame: assessed from baseline to week 24
C3(g/l)will be tested to determine whether the interventions measures will affect the inflammatory biomarkers
assessed from baseline to week 24
biological index
Time Frame: assessed from baseline to week 24
IL-6(U/L) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
assessed from baseline to week 24
biological index
Time Frame: assessed from baseline to week 24
brain-derived neurotrophic factor( BDNF) will be tested to determine whether the interventions measures will affect the BDNF.
assessed from baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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