Clinical trial NCT02032576: Predictors of the Response and Relapse/Recurrence After ECT for Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Episode
Keywords: major depressive episode, electroconvulsive therapy
Lead sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2014-01-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Predictors of ECT response
timeFrame: an expected average of 50 days after initiation of ECT
measure: Predictors of relapse/recurrence after ECT
timeFrame: 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 outcomes:
measure: The changes of plasma brain-derived neurotrophic factor (BDNF) level after ECT
timeFrame: Prior to undergoing the first ECT and at an expected average of 50 days, plasma BDNF will be tested.
measure: The changes of cognitive functions after ECT
timeFrame: Neuropsychological test will be performed before the first ECT and at an expected average of 50 days.
measure: Assessments of safety for general adverse events after ECT
timeFrame: UKU Side Effect Rating Scale will be assessed before ECT, after every 10 days, till to an expected average of 50 days.
measure: The changes of quality of life after ECT
timeFrame: Short-Form 36 (SF-36) will be examined before the first ECT and at an expected average of 50 days.
measure: The changes of psychosocial functioning after ECT
timeFrame: Work and Social Adjustment Scale (WSAS) will be examined before the first ECT and at an expected average of 50 days.
measure: The changes of auditory evoked potentials (AEP) after ECT
timeFrame: Prior to undergoing the first ECT and at an expected average of 50 days, AEP will be tested.
measure: The changes of electroencephalography (EEG) after ECT
timeFrame: Prior to undergoing the first ECT and at an expected average of 50 days, EEG will be tested.
measure: The changes of RNA after ECT
timeFrame: Prior to undergoing the first ECT and at an expected average of 50 days, RNA will be extracted from the blood.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kai-Suan Psychiatric Hospital
Study officials:
affiliation: Kai-Suan Psychiatric Hospital
name: Ching-Hua Lin, M.D.
role: STUDY_CHAIR
References:
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. doi: 10.1038/sj.npp.1300135.
citation: Bourgon LN, Kellner CH. Relapse of depression after ECT: a review. J ECT. 2000 Mar;16(1):19-31. doi: 10.1097/00124509-200003000-00003.
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 depression. J Clin Psychiatry. 2007 Apr;68(4):512-7. doi: 10.4088/jcp.v68n0404.