Predictors of the Response and Relapse/Recurrence After ECT for Depressed Patients

January 7, 2014 updated by: Ching-Hua Lin, MD, PhD, Kaohsiung Kai-Suan Psychiatric Hospital

Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive therapy (ECT) response. Although ECT is highly effective for treatment of patients with major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT, to predict ECT response early, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT.

Methods: Patients with major depressive episode who require ECT treatment will be enrolled. ECT will be performed regularly. The 17-item Hamilton Rating Scale for Depression (HAMD-17) and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Other measures also will be performed before the first ECT, at an expected average of 50 days, and at the end of follow-up period. Predictors of the response and relapse/recurrence after ECT and early prediction of ECT response will be obtained by statistic methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: Electroconvulsive therapy (ECT) is a safe and the most effective treatment for patients with major depressive episode, but the mechanism underlying the therapeutic action of this treatment is still unknown. Psychiatrists have long sought a quantifiable biomarker of ECT treatment response. Till now, no biomarker of ECT is used in clinical practice, but potential biomarkers that have been studied include brain-derived neurotrophic factor (BDNF), DNA polymorphism, RNA, electroencephalogram (EEG), auditory evoked potential (AEP), and cognitive function test. Although ECT is highly effective for treatment of major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT for patients with major depressive episode, to predict the ECT response, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT.

Methods: Subjects with major depressive episode diagnosed according to DSM-IV criteria who require ECT treatment will be enrolled for study. ECT will be performed regularly using a brief-pulse, constant-current device. ECT will be given two or three times a week. The 17-item Hamilton Rating Scale for Depression (HAMD-17), Clinical Global Impression-severity (CGI-S), global assessment scale (GAF), UKU side effect rating scale and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Other measures collected before ECT and at an expected average of 50 days include Zung's Depression Scale (SDS), Short-Form 36 (SF-36), Work and Social Adjustment Scale (WSAS), plasma BDNF level, auditory evoked potentials (AEP), electroencephalography (EEG), neuropsychological test, and RNA. After ECT, CGI-S, HAMD-17, GAF and WSAS are reexamined monthly for 6 months. The definition of relapse/recurrence will be readmission, a HAM-D-17 score at least 18, or a CGI-S score at least 4 during the follow-up period. A logistic regression model will be used to obtain the predictors for ECT response. To establish the early prediction of ECT response, receiver operating characteristic curve (ROC) will be used to determine the cutoff point. Possible predictors related to relapse/recurrence will be analyzed using the Cox proportional hazards regression model.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 802
        • Kai-Suan Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of major depressive disorder or bipolar depression
  • Poor drug response
  • Severity or urgency of illness

Exclusion Criteria:

  • Subjects cannot write the imform consents
  • Subjects with severe physical illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECT for depressed patients
electroconvulsive therapy with a bipolar brief pulse square wave
Device: ECT for depressed patients
electroconvulsive therapy with a bipolar brief pulse square wave
Other Names:
  • bilateral ECT with a bipolar brief pulse square wave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of ECT response
Time Frame: an expected average of 50 days after initiation of ECT
Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Potential factors related to ECT response will be assayed. Early prediction model of response will be established.
an expected average of 50 days after initiation of ECT
Predictors of relapse/recurrence after ECT
Time Frame: After ECT, HAMD-17 will be assessed monthly until the relapse/recurrence of the major depressive episode during the 6-month follow-up period.
The definition of relapse/recurrence of the major depressive episode will be readmission or a HAMD-17 score at least 18. Predictors (demographic and clinical variables) associated with time to relapse/recurrence during the 6-month follow-up period will be assayed using survival analysis.
After ECT, HAMD-17 will be assessed monthly until the relapse/recurrence of the major depressive episode during the 6-month follow-up period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of plasma brain-derived neurotrophic factor (BDNF) level after ECT
Time Frame: Prior to undergoing the first ECT and at an expected average of 50 days, plasma BDNF will be tested.
The association between response and the change of BDNF will be examined.
Prior to undergoing the first ECT and at an expected average of 50 days, plasma BDNF will be tested.
The changes of cognitive functions after ECT
Time Frame: Neuropsychological test will be performed before the first ECT and at an expected average of 50 days.
The impact of ECT on cognitive functions will be assayed.
Neuropsychological test will be performed before the first ECT and at an expected average of 50 days.
Assessments of safety for general adverse events after ECT
Time Frame: UKU Side Effect Rating Scale will be assessed before ECT, after every 10 days, till to an expected average of 50 days.
General adverse events were evaluated by a standardized the UKU Side Effect Rating Scale.
UKU Side Effect Rating Scale will be assessed before ECT, after every 10 days, till to an expected average of 50 days.
The changes of quality of life after ECT
Time Frame: Short-Form 36 (SF-36) will be examined before the first ECT and at an expected average of 50 days.
The association between response and the change of SF-36 will be examined.
Short-Form 36 (SF-36) will be examined before the first ECT and at an expected average of 50 days.
The changes of psychosocial functioning after ECT
Time Frame: Work and Social Adjustment Scale (WSAS) will be examined before the first ECT and at an expected average of 50 days.
The association between response and the change of WSAS will be examined.
Work and Social Adjustment Scale (WSAS) will be examined before the first ECT and at an expected average of 50 days.
The changes of auditory evoked potentials (AEP) after ECT
Time Frame: Prior to undergoing the first ECT and at an expected average of 50 days, AEP will be tested.
The association between response and the change of AEP will be examined.
Prior to undergoing the first ECT and at an expected average of 50 days, AEP will be tested.
The changes of electroencephalography (EEG) after ECT
Time Frame: Prior to undergoing the first ECT and at an expected average of 50 days, EEG will be tested.
The impact of ECT on EEG will be assayed.
Prior to undergoing the first ECT and at an expected average of 50 days, EEG will be tested.
The changes of RNA after ECT
Time Frame: Prior to undergoing the first ECT and at an expected average of 50 days, RNA will be extracted from the blood.
The association between response and the change of RNA will be examined.
Prior to undergoing the first ECT and at an expected average of 50 days, RNA will be extracted from the blood.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Kai-Suan Psychiatric Hospital

Investigators

  • Study Chair: Ching-Hua Lin, M.D., Kai-Suan Psychiatric Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 3, 2012

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSPH-2008-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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