Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04518319
• Other study ID #: 20200815SMHC-sk-YChen
• Status: Suspended
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: November 2024

Study information

• Verified date: April 2023
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Metabolic Syndrome
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome	Change in the the MATRICS consensus cognitive battery between randomization	from baseline to 3 months after treatment
Secondary	change in the Schizophrenia Quality of Life Scale(SQLS)	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.	assessed from baseline to 3 months after treatment
Secondary	change in the scale of social function in psychosis inpatients	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.	assessed from baseline to 3 months after treatment
Secondary	metabolic indicators	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).	assessed from baseline to week 24
Secondary	biological index	CRP(mg/dl) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.	assessed from baseline to week 24
Secondary	biological index	C3(g/l)will be tested to determine whether the interventions measures will affect the inflammatory biomarkers	assessed from baseline to week 24
Secondary	biological index	IL-6(U/L) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.	assessed from baseline to week 24
Secondary	biological index	brain-derived neurotrophic factor( BDNF) will be tested to determine whether the interventions measures will affect the BDNF.	assessed from baseline to week 24