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Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

Primary Purpose

Schizophrenia

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Omega-3 polyunsaturated fatty acids
Xbox aerobic exercise
transcranial direct current stimulation,tDCS
Olanzapine
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

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Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

omega-3 polyunsaturated fatty acids

Xbox aerobic exercise

transcranial direct current stimulation

olanzapine

Arm Description

Patients randomized to the omega-3 polyunsaturated fatty acids will receive treatment with 1200mg per day plus on-going olanzapine.

Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine.

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 randomized to the olanzapine will receive conventional treatment-olanzapine.

Outcomes

Primary Outcome Measures

Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
Change in the the MATRICS consensus cognitive battery between randomization

Secondary Outcome Measures

change in the Schizophrenia Quality of Life Scale(SQLS)
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.
change in the scale of social function in psychosis inpatients
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.
metabolic indicators
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).
biological index
CRP(mg/dl) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
biological index
C3（g/l）will be tested to determine whether the interventions measures will affect the inflammatory biomarkers
biological index
IL-6(U/L) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
biological index
brain-derived neurotrophic factor( BDNF) will be tested to determine whether the interventions measures will affect the BDNF.

Full Information

First Posted
August 13, 2020
Last Updated
April 14, 2023
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT04518319
Brief Title
Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome
Official Title
Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
The COVID-19 affects the recruitment of patients.
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
omega-3 polyunsaturated fatty acids
Arm Type
Experimental
Arm Description
Patients randomized to the omega-3 polyunsaturated fatty acids will receive treatment with 1200mg per day plus on-going olanzapine.
Arm Title
Xbox aerobic exercise
Arm Type
Experimental
Arm Description
Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine.
Arm Title
transcranial direct current stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
olanzapine
Arm Type
Experimental
Arm Description
Patients randomized to the olanzapine will receive conventional treatment-olanzapine.
Intervention Type
Drug
Intervention Name(s)
Omega-3 polyunsaturated fatty acids
Intervention Description
Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.
Intervention Type
Behavioral
Intervention Name(s)
Xbox aerobic exercise
Intervention Description
Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation,tDCS
Intervention Description
Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Patients will take only olanzapine pills.
Primary Outcome Measure Information:
Title
Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
Description
Change in the the MATRICS consensus cognitive battery between randomization
Time Frame
from baseline to 3 months after treatment
Secondary Outcome Measure Information:
Title
change in the Schizophrenia Quality of Life Scale(SQLS)
Description
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.
Time Frame
assessed from baseline to 3 months after treatment
Title
change in the scale of social function in psychosis inpatients
Description
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.
Time Frame
assessed from baseline to 3 months after treatment
Title
metabolic indicators
Description
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).
Time Frame
assessed from baseline to week 24
Title
biological index
Description
CRP(mg/dl) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
Time Frame
assessed from baseline to week 24
Title
biological index
Description
C3（g/l）will be tested to determine whether the interventions measures will affect the inflammatory biomarkers
Time Frame
assessed from baseline to week 24
Title
biological index
Description
IL-6(U/L) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
Time Frame
assessed from baseline to week 24
Title
biological index
Description
brain-derived neurotrophic factor( BDNF) will be tested to determine whether the interventions measures will affect the BDNF.
Time Frame
assessed from baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets the Diagnostic and Statistical Manual of Mental Disorder,Fifth Edition(DSM-V) criteria for Schizophrenia. Patients have got standard treatment of olanzapine monotherapy for more than 6 months, PANSS baseline ≤ 60. Meets the ATP-III criteria for metabolic syndrome. Male or female subjects aged 18-60 years, education level of junior high school for above. The patient fully understand and signed the informed consent form. Exclusion Criteria: 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. 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. History of diabetes, hyperlipidemia and other metabolic abnormalities. Due to other reasons, the researchers considered it unsuitable to participate in this clinical trial. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Chen
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

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Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

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