Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Omega-3 polyunsaturated fatty acids

Intervention Type DRUG

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

Xbox aerobic exercise

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

Group Type EXPERIMENTAL

Xbox aerobic exercise

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

transcranial direct current stimulation,tDCS

Intervention Type DEVICE

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

olanzapine

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

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

Patients will take only olanzapine pills.

Interventions

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Omega-3 polyunsaturated fatty acids

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

Intervention Type DRUG

Xbox aerobic exercise

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

Intervention Type BEHAVIORAL

transcranial direct current stimulation,tDCS

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

Intervention Type DEVICE

Olanzapine

Patients will take only olanzapine pills.

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No