Clinical trial NCT03651674: Longitudinal Effect of Electroconvulsive Therapy on Schizophrenia and Bipolar Disorder: a MRI Study
Official title: Longitudinal Effect of Electroconvulsive Therapy on Schizophrenia and Bipolar Disorder: a MRI Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia, Bipolar Disorder
Lead sponsor: Xidian University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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;

Primary outcomes:
measure: Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia;
timeFrame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
measure: Change of Bech-Rafaelsen Mania Rating Scale (BRMS) for Bipolar disorder
timeFrame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
measure: Change of Hamilton Anxiety Scale (HAMA) for Bipolar disorder
timeFrame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
measure: Change of Hamilton depression scale (HAMD) for Bipolar disorder
timeFrame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Secondary outcomes:
measure: Changes of brain gray matter, white matter and functional based on MRI data analysis
timeFrame: 2 time points:baseline, the end of the three-week treatment]
measure: Change of Mini-Mental State Examination
timeFrame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Other outcomes:
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