Clinical trial NCT04518319: Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome
Official title: Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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Primary outcomes:
measure: Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
timeFrame: from baseline to 3 months after treatment
Secondary outcomes:
measure: change in the Schizophrenia Quality of Life Scale(SQLS)
timeFrame: assessed from baseline to 3 months after treatment
measure: change in the scale of social function in psychosis inpatients
timeFrame: assessed from baseline to 3 months after treatment
measure: metabolic indicators
timeFrame: assessed from baseline to week 24
measure: biological index
timeFrame: assessed from baseline to week 24
measure: biological index
timeFrame: assessed from baseline to week 24
measure: biological index
timeFrame: assessed from baseline to week 24
measure: biological index
timeFrame: assessed from baseline to week 24
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Yan Chen
role: PRINCIPAL_INVESTIGATOR
References: