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

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ClinicalTrials.gov Identifier: NCT02032576
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Ching-Hua Lin, MD, PhD, Kaohsiung Kai-Suan Psychiatric Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Major Depressive Episode Device: ECT for depressed patients Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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 Name: bilateral ECT with a bipolar brief pulse square wave




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032576


Locations
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Taiwan
Kai-Suan Psychiatric Hospital
Kaohsiung, Taiwan, 802
Sponsors and Collaborators
Kaohsiung Kai-Suan Psychiatric Hospital
Investigators
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Study Chair: Ching-Hua Lin, M.D. Kai-Suan Psychiatric Hospital

Publications of Results:
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Responsible Party: Ching-Hua Lin, MD, PhD, Chief of Adult Psychiatry Department, Kaohsiung Kai-Suan Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT02032576     History of Changes
Other Study ID Numbers: KSPH-2008-12
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Ching-Hua Lin, MD, PhD, Kaohsiung Kai-Suan Psychiatric Hospital:
major depressive episode, electroconvulsive therapy
Additional relevant MeSH terms:
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Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders