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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia, Bipolar Disorder
• Intervention / Treatment: Device: ECT treatment; Drug: Drug treatment

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Qin; Phone Number: 86-02981891070; Email: wqin@xidian.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xidian University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Serotonin Antagonists; GABA Agents; GABA Antagonists; Olanzapine; Clozapine
• Other Study ID Numbers: 81471815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No