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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia, Bipolar Disorder

Intervention / Treatment
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* Device: ECT treatment
* Drug: Drug treatment


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ECT treatment<br>Patients received bilateral temporal modified ECT (MECT) for three weeks,four times a week. Meanwhile, they also had antipsychotic drugs. | Device: ECT treatment<br>* Patients had bilateral temporal modified ECT four times a week for 3 consecutive weeks<br>|
| Sham Comparator: Drug treatment<br>Patients only received antipsychotic drugs during observation period. | Drug: Drug treatment<br>* Patients only have antipsychotic drugs<br>* Other names: olanzapine,clozapine,magnesium valproat,etc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 
| 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 |