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

20200815SMHC-sk-YChen

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.

2020-10-01

2024-11-01

2024-11-01

Early phase I

120

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. -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-04-18