Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

NCT04518319 | Suspended Phase 2

• 1 other identifier: 20200815SMHC-sk-YChen
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome

  Change in the the MATRICS consensus cognitive battery between randomization

  from baseline to 3 months after treatment

Secondary Outcomes (7)

• change in the Schizophrenia Quality of Life Scale(SQLS)

  assessed from baseline to 3 months after treatment

• change in the scale of social function in psychosis inpatients

  assessed from baseline to 3 months after treatment

• metabolic indicators

  assessed from baseline to week 24

• biological index

  assessed from baseline to week 24

• biological index

  assessed from baseline to week 24

Study Arms (4)

omega-3 polyunsaturated fatty acids

EXPERIMENTAL

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

Xbox aerobic exercise

EXPERIMENTAL

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

Behavioral: Xbox aerobic exercise

transcranial direct current stimulation

EXPERIMENTAL

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

olanzapine

EXPERIMENTAL

Patients randomized to the olanzapine will receive conventional treatment-olanzapine.

Drug: Olanzapine

Interventions

Omega-3 polyunsaturated fatty acids DRUG

Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.

omega-3 polyunsaturated fatty acids

Xbox aerobic exercise BEHAVIORAL

Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.

Xbox aerobic exercise

transcranial direct current stimulation,tDCS DEVICE

Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.

transcranial direct current stimulation

Olanzapine DRUG

Patients will take only olanzapine pills.

olanzapine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Docosahexaenoic Acids; Transcranial Direct Current Stimulation; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yan Chen

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 19, 2020
• Study Start: October 1, 2020
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)