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

NCT ID: NCT03651674

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2020-04-01

Brief 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.

Conditions

Schizophrenia, Bipolar Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ECT treatment

Patients received bilateral temporal modified ECT (MECT) for three weeks,four times a week. Meanwhile, they also had antipsychotic drugs.

Group Type: ACTIVE_COMPARATOR

ECT treatment

Intervention Type: DEVICE

Patients had bilateral temporal modified ECT four times a week for 3 consecutive weeks

Drug treatment

Patients only received antipsychotic drugs during observation period.

Group Type: SHAM_COMPARATOR

Drug treatment

Intervention Type: DRUG

Patients only have antipsychotic drugs

Interventions

ECT treatment

Patients had bilateral temporal modified ECT four times a week for 3 consecutive weeks

Intervention Type: DEVICE

Drug treatment

Patients only have antipsychotic drugs

Intervention Type: DRUG

Other Intervention Names

olanzapine,clozapine,magnesium valproat,etc.

Eligibility Criteria

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;

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xidian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Wei Qin

Role: CONTACT

wqin@xidian.edu.cn

86-02981891070

Other Identifiers

81471815

Identifier Type: -

Identifier Source: org_study_id