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

NCT03651674 | Unknown

• 1 other identifier: 81471815
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia, Bipolar Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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]

• Change of Mini-Mental State Examination

  3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment

Study Arms (2)

ECT treatment

ACTIVE COMPARATOR

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

Device: ECT treatment

Drug treatment

SHAM COMPARATOR

Patients only received antipsychotic drugs during observation period.

Drug: Drug treatment

Interventions

ECT treatment DEVICE

Patients had bilateral temporal modified ECT four times a week for 3 consecutive weeks

ECT treatment

Drug treatment DRUG

Patients only have antipsychotic drugs

Also known as: olanzapine,clozapine,magnesium valproat,etc.

Drug treatment

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xidian University: lead

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Wei Qin

CONTACT

86-02981891070; wqin@xidian.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 29, 2018
• Study Start: September 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: April 1, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share