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The COVID-19 affects the recruitment of patients.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Xbox aerobic exercise | Experimental | Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine. |
|
| 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. |
|
| olanzapine | Experimental | Patients randomized to the olanzapine will receive conventional treatment-olanzapine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 polyunsaturated fatty acids | Drug | Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine. |
|
| 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 |
| 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 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Yan Chen | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D065908 | Transcranial Direct Current Stimulation |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Xbox aerobic exercise | Behavioral | Patients will do Xbox aerobic exercise 30min per day plus on olanzapine. |
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| transcranial direct current stimulation,tDCS | Device | Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine. |
|
| Olanzapine | Drug | Patients will take only olanzapine pills. |
|
| 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 |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |