NCT04518319

Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Omega-3 polyunsaturated fatty acids	Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.
BEHAVIORAL	Xbox aerobic exercise	Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.
DEVICE	transcranial direct current stimulation,tDCS	Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.
DRUG	Olanzapine	Patients will take only olanzapine pills.

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2020-08-19
• Last updated: 2023-04-18

Locations

1 site across 1 country: China