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

Major Depressive Episode Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032576
• Other study ID #: KSPH-2008-12
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2012
• Last updated: January 7, 2014
• Start date: January 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Kaohsiung Kai-Suan Psychiatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Major Depressive Episode

Intervention

Device:
• ECT for depressed patients
electroconvulsive therapy with a bipolar brief pulse square wave

Locations

Country	Name	City	State
Taiwan	Kai-Suan Psychiatric Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Kai-Suan Psychiatric Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Bourgon LN, Kellner CH. Relapse of depression after ECT: a review. J ECT. 2000 Mar;16(1):19-31. Review. — View Citation

Marano CM, Phatak P, Vemulapalli UR, Sasan A, Nalbandyan MR, Ramanujam S, Soekadar S, Demosthenous M, Regenold WT. Increased plasma concentration of brain-derived neurotrophic factor with electroconvulsive therapy: a pilot study in patients with major dep — View Citation

Wahlund B, von Rosen D. ECT of major depressed patients in relation to biological and clinical variables: a brief overview. Neuropsychopharmacology. 2003 Jul;28 Suppl 1:S21-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors of ECT response	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	No
Primary	Predictors of relapse/recurrence after ECT	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.	No
Secondary	The changes of plasma brain-derived neurotrophic factor (BDNF) level after ECT	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.	No
Secondary	The changes of cognitive functions after ECT	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.	Yes
Secondary	Assessments of safety for general adverse events after ECT	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.	Yes
Secondary	The changes of quality of life after ECT	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.	No
Secondary	The changes of psychosocial functioning after ECT	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.	No
Secondary	The changes of auditory evoked potentials (AEP) after ECT	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.	No
Secondary	The changes of electroencephalography (EEG) after ECT	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.	Yes
Secondary	The changes of RNA after ECT	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.	No