Longitudinal Effect of Electroconvulsive Therapy on Schizophrenia and Bipolar Disorder: a MRI Study

Schizophrenia, Bipolar Disorder Clinical Trial

Official title:

Longitudinal Effect of Electroconvulsive Therapy on Schizophrenia and Bipolar Disorder: a MRI Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03651674
• Other study ID #: 81471815
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2018
• Source: Xidian University
• Contact: Wei Qin
• Phone: 86-02981891070
• Email: wqin[@]xidian.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For more severe and treatment-resistant cases in schizophrenia and bipolar disorder, electroconvulsive therapy (ECT) is often very effective. The purpose of this study is to investigate the brain structure and function changes after ECT treatment. The neuroimaging marker which may predict the outcome of ECT is also studied in this research.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• International classification of diseases (ICD) diagnosis of Schizophrenia and bipolar disorder;

• Ages 15-70

• All participants are ethnic Han

• Not received ECT treatment before

• PANSS = 60 for schizophrenia subjects

• The patient's written informed consent can be obtained. If the patient is incapacitated during the onset period, the written informed consent of the legal guardian is required.

Exclusion Criteria:

• Those with mental retardation, generalized developmental disorders,delirium, dementia, memory impairment or cognitive impairment that meet the diagnostic criteria of ICD-10;

• Patients with cognitive impairment, such as Parkinson's, multiple sclerosis, stroke, and patients who meet the diagnostic criteria for ICD-10 alcohol dependence (except nicotine dependence);

• The course of the disease is very short (fast phase inversion), such as 4 or more different mood abnormalities (depression, mild mania, mania, mental illness) in one year;

• With severe unstable physical diseases; diagnosed diabetes, thyroid disease, hypertension, heart disease, etc.;

• Narrow angle glaucoma;

• With a history of epilepsy, except those with febrile seizures;

• Have or have had drug-induced malignant syndrome and severe tardive dyskinesia;

• With serious suicide attempts;

• Cannot take medication as directed by their doctors, or who do not have guardians;

• Pregnant or lactating women, or those who plan to become pregnant;

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Schizophrenia
• Schizophrenia, Bipolar Disorder

Intervention

Device:
• ECT treatment
Patients had bilateral temporal modified ECT four times a week for 3 consecutive weeks

Drug:
• Drug treatment
Patients only have antipsychotic drugs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xidian University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia;	Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.	3 time points: baseline, the end of the three-week treatment,3 months after ECT or drugs treatment
Primary	Change of Bech—Rafaelsen Mania Rating Scale (BRMS) for Bipolar disorder	Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.	3 time points: baseline, the end of the three-week treatment,3 months after ECT or drugs treatment
Primary	Change of Hamilton Anxiety Scale (HAMA) for Bipolar disorder	Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.	3 time points: baseline, the end of the three-week treatment,3 months after ECT or drugs treatment
Primary	Change of Hamilton depression scale (HAMD) for Bipolar disorder	Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.	3 time points: baseline, the end of the three-week treatment,3 months after ECT or drugs treatment
Secondary	Changes of brain gray matter, white matter and functional based on MRI data analysis	The changes of gray matter volume,structural integrity of white matter,and brain function during resting state after treatment will be analyzed.	2 time points:baseline, the end of the three-week treatment]
Secondary	Change of Mini-Mental State Examination	Scale change from baseline will be documented after three weeks treatment and 3 months follow-up visit.	3 time points: baseline, the end of the three-week treatment,3 months after ECT or drugs treatment