Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

Phase 2

Suspended

• Conditions: Schizophrenia
• Interventions: Behavioral: Xbox aerobic exercise; Device: transcranial direct current stimulation,tDCS; Drug: Olanzapine; Drug: Omega-3 polyunsaturated fatty acids

• Registration Number: NCT04518319
• Lead Sponsor: Shanghai Mental Health Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-19
• Study Start: 2020-10-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xbox aerobic exercise	Xbox aerobic exercise	Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine.
transcranial direct current stimulation	transcranial direct current stimulation,tDCS	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	Olanzapine	Patients randomized to the olanzapine will receive conventional treatment-olanzapine.
omega-3 polyunsaturated fatty acids	Omega-3 polyunsaturated fatty acids	Patients randomized to the omega-3 polyunsaturated fatty acids will receive treatment with 1200mg per day plus on-going olanzapine.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
biological index	assessed from baseline to week 24	brain-derived neurotrophic factor( BDNF) will be tested to determine whether the interventions measures will affect the BDNF.
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).

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China