- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518319
Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome
April 14, 2023 updated by: Yan CHEN, Shanghai Mental Health Center
Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome
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.
Study Overview
Status
Suspended
Conditions
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Shanghai Mental Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Meets the Diagnostic and Statistical Manual of Mental Disorder,Fifth Edition(DSM-V) criteria for Schizophrenia.
- Patients have got standard treatment of olanzapine monotherapy for more than 6 months, PANSS baseline ≤ 60.
- Meets the ATP-III criteria for metabolic syndrome.
- Male or female subjects aged 18-60 years, education level of junior high school for above.
- The patient fully understand and signed the informed consent form.
Exclusion Criteria:
- 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.
- 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.
- History of diabetes, hyperlipidemia and other metabolic abnormalities.
Due to other reasons, the researchers considered it unsuitable to participate in this clinical trial.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.
|
Experimental: Xbox aerobic exercise
Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine.
|
Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.
|
Experimental: transcranial direct current stimulation
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.
|
Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.
|
Experimental: olanzapine
Patients randomized to the olanzapine will receive conventional treatment-olanzapine.
|
Patients will take only olanzapine pills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
Time Frame: from baseline to 3 months after treatment
|
Change in the the MATRICS consensus cognitive battery between randomization
|
from baseline to 3 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in the Schizophrenia Quality of Life Scale(SQLS)
Time Frame: 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.
|
assessed from baseline to 3 months after treatment
|
change in the scale of social function in psychosis inpatients
Time Frame: 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.
|
assessed from baseline to 3 months after treatment
|
metabolic indicators
Time Frame: 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).
|
assessed from baseline to week 24
|
biological index
Time Frame: assessed from baseline to week 24
|
CRP(mg/dl) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
|
assessed from baseline to week 24
|
biological index
Time Frame: assessed from baseline to week 24
|
C3(g/l)will be tested to determine whether the interventions measures will affect the inflammatory biomarkers
|
assessed from baseline to week 24
|
biological index
Time Frame: assessed from baseline to week 24
|
IL-6(U/L) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
|
assessed from baseline to week 24
|
biological index
Time Frame: assessed from baseline to week 24
|
brain-derived neurotrophic factor( BDNF) will be tested to determine whether the interventions measures will affect the BDNF.
|
assessed from baseline to week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Anticipated)
November 1, 2024
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 18, 2020
First Posted (Actual)
August 19, 2020
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 14, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Glucose Metabolism Disorders
- Metabolic Diseases
- Neurocognitive Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Insulin Resistance
- Hyperinsulinism
- Cognition Disorders
- Schizophrenia
- Metabolic Syndrome
- Cognitive Dysfunction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Olanzapine
Other Study ID Numbers
- 20200815SMHC-sk-YChen
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
Bradley LegaRecruiting
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Omega-3 polyunsaturated fatty acids
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBreast Neoplasms | ArthralgiaUnited States
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... and other collaboratorsCompleted
-
Evandro Chagas Institute of Clinical ResearchAndrea Silvestre de Sousa, MD PhD; Pedro Emmanuel Alvarenga Americano do Brasil... and other collaboratorsCompletedChagas CardiomyopathyBrazil
-
Hadir F. El-DessoukyCompletedChronic Periodontitis | Menopausal Patients | Omega 3 Fatty AcidsSaudi Arabia
-
Jian SuoUnknown
-
The University of New South WalesOcean Nutrition; Your Health Inc.; Sphere HealthcareUnknown
-
Bethan HusseyUnknown
-
Kuang Tien General HospitalCompletedMigraine | Omega-3 Polyunsaturated Fatty AcidsTaiwan
-
Giovanni StrippoliUniversity of SydneyCompletedEnd Stage Renal Disease | Diet Habit
-
Retina Foundation of the SouthwestDSM Nutritional Products, Inc.CompletedInfant DevelopmentUnited States