Back to results

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

Primary Purpose

Schizophrenia, Bipolar Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ECT treatment

Drug treatment

About this trial

This is an interventional basic science trial for Schizophrenia, Bipolar Disorder

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ECT treatment

Drug treatment

Arm Description

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

Patients only received antipsychotic drugs during observation period.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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.

Change of Mini-Mental State Examination

Scale change from baseline will be documented after three weeks treatment and 3 months follow-up visit.

Full Information

NCT ID

NCT03651674

First Posted

August 23, 2018

Last Updated

August 28, 2018

Sponsor

Xidian University

1. Study Identification

Unique Protocol Identification Number

NCT03651674

Brief Title

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

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 20, 2018 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xidian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Bipolar Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ECT treatment

Arm Type

Active Comparator

Arm Description

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

Arm Title

Drug treatment

Arm Type

Sham Comparator

Arm Description

Patients only received antipsychotic drugs during observation period.

Intervention Type

Device

Intervention Name(s)

ECT treatment

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Drug treatment

Other Intervention Name(s)

olanzapine,clozapine,magnesium valproat,etc.

Intervention Description

Patients only have antipsychotic drugs

Primary Outcome Measure Information:

Title

Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia;

Description

Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.

Time Frame

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

Title

Change of Bech-Rafaelsen Mania Rating Scale (BRMS) for Bipolar disorder

Description

Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.

Time Frame

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

Title

Change of Hamilton Anxiety Scale (HAMA) for Bipolar disorder

Description

Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.

Time Frame

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

Title

Change of Hamilton depression scale (HAMD) for Bipolar disorder

Description

Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.

Time Frame

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

Secondary Outcome Measure Information:

Title

Changes of brain gray matter, white matter and functional based on MRI data analysis

Description

The changes of gray matter volume,structural integrity of white matter,and brain function during resting state after treatment will be analyzed.

Time Frame

2 time points:baseline, the end of the three-week treatment]

Title

Change of Mini-Mental State Examination

Description

Scale change from baseline will be documented after three weeks treatment and 3 months follow-up visit.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Qin

Phone

86-02981891070

wqin@xidian.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs