Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

Study Overview
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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.

Official Title
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Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Omega-3 polyunsaturated fatty acids
* Behavioral: Xbox aerobic exercise
* Device: transcranial direct current stimulation,tDCS
* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3 polyunsaturated fatty acids<br>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<br>* Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.<br>|
| Experimental: Xbox aerobic exercise<br>Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine. | Behavioral: Xbox aerobic exercise<br>* Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.<br>|
| Experimental: transcranial direct current stimulation<br>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<br>* Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.<br>|
| Experimental: olanzapine<br>Patients randomized to the olanzapine will receive conventional treatment-olanzapine. | Drug: Olanzapine<br>* Patients will take only olanzapine pills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | assessed from baseline to 3 months after treatment | 
| 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. | assessed from baseline to 3 months after treatment | 
| 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). | assessed from baseline to week 24 | 
| biological index | 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 | 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 | 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 | brain-derived neurotrophic factor( BDNF) will be tested to determine whether the interventions measures will affect the BDNF. | assessed from baseline to week 24 |