Schizophrenia, Bipolar Disorder
Conditions
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.
Interventions
DEVICEECT treatment
Patients had bilateral temporal modified ECT four times a week for 3 consecutive weeks
DRUGDrug treatment
Patients only have antipsychotic drugs
Sponsors
Xidian University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactWei Qin
Outcome results
None listed