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

Xidian University

Status: Unknown

Conditions: Schizophrenia, Bipolar Disorder

Treatments: Device: ECT treatment; Drug: Drug treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03651674

81471815

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ECT treatment

Active Comparator group

Description:

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

Treatment:

Device: ECT treatment

Drug treatment

Sham Comparator group

Description:

Patients only received antipsychotic drugs during observation period.

Treatment:

Drug: Drug treatment