Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

Shanghai Mental Health Center

Status and phase: Suspended; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Omega-3 polyunsaturated fatty acids; Behavioral: Xbox aerobic exercise; Drug: Olanzapine; Device: transcranial direct current stimulation,tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04518319

20200815SMHC-sk-YChen

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

omega-3 polyunsaturated fatty acids

Experimental group

Description:

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

Treatment:

Drug: Omega-3 polyunsaturated fatty acids

Xbox aerobic exercise

Experimental group

Description:

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

Treatment:

Behavioral: Xbox aerobic exercise

transcranial direct current stimulation

Experimental group

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.

Treatment:

Device: transcranial direct current stimulation,tDCS

olanzapine

Experimental group

Description:

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

Treatment:

Drug: Olanzapine