Schizophrenia
Conditions
Brief summary
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.
Interventions
Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.
BEHAVIORALXbox aerobic exercise
Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.
DEVICEtranscranial direct current stimulation,tDCS
Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.
DRUGOlanzapine
Patients will take only olanzapine pills.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome | from baseline to 3 months after treatment | Change in the the MATRICS consensus cognitive battery between randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in the Schizophrenia Quality of Life Scale(SQLS) | assessed from baseline to 3 months after treatment | 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. |
| change in the scale of social function in psychosis inpatients | assessed from baseline to 3 months after treatment | 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. |
| metabolic indicators | assessed from baseline to week 24 | 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). |
| biological index | assessed from baseline to week 24 | CRP(mg/dl) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers. |
Countries
China
Outcome results
None listed