Predictors of the Response and Relapse/Recurrence After ECT for Depressed Patients
Condition: Major Depressive Episode
MeSH terms: Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): ECT for depressed patients
Intervention type(s): Device
Intervention description(s): electroconvulsive therapy with a bipolar brief pulse square wave
Other intervention name(s): bilateral ECT with a bipolar brief pulse square wave
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depressive episode, electroconvulsive therapy