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

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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.

    -

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Omega-3 polyunsaturated fatty acids
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.
Behavioral: Xbox aerobic exercise
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.
Device: transcranial direct current stimulation,tDCS
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.
Drug: Olanzapine
Patients will take only olanzapine pills.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200815SMHC-sk-YChen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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