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

Not Applicable

• Conditions: Schizophrenia, Bipolar Disorder
• Interventions: Device: ECT treatment; Drug: Drug treatment

• Registration Number: NCT03651674
• Lead Sponsor: Xidian University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29
• Study Start: 2018-09-20
• Primary Completion: 2019-12-31
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECT treatment	ECT treatment	Patients received bilateral temporal modified ECT (MECT) for three weeks,four times a week. Meanwhile, they also had antipsychotic drugs.
Drug treatment	Drug treatment	Patients only received antipsychotic drugs during observation period.

Primary Outcome Measures

Name	Time	Method
Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia;	3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment	Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Bech-Rafaelsen Mania Rating Scale (BRMS) for Bipolar disorder	3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment	Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Hamilton Anxiety Scale (HAMA) for Bipolar disorder	3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment	Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Hamilton depression scale (HAMD) for Bipolar disorder	3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment	Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Changes of brain gray matter, white matter and functional based on MRI data analysis	2 time points:baseline, the end of the three-week treatment]	The changes of gray matter volume,structural integrity of white matter,and brain function during resting state after treatment will be analyzed.
Change of Mini-Mental State Examination	3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment	Scale change from baseline will be documented after three weeks treatment and 3 months follow-up visit.