MR Imaging Biomarkers of Disease Response to ECT (Electroconvulsive Therapy) in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to (a) measure how brain structure, metabolism (how the brain
      uses energy), and function predict response to electroconvulsive therapy (ECT) for treatment
      of depression; and (b) measure how ECT changes brain metabolism and function. We will ask you
      to undergo magnetic resonance imaging (MRI) at three sessions: (1) prior to your first ECT
      therapy session, (2) after having 4-6 ECT therapy sessions, and (3) approximately two months
      following your first ECT therapy sessions.
    

Detailed description: 
      We aim to study potential MR imaging biomarkers derived from f-MRI (functional magnetic
      resonance imaging), DTI (diffusion tensor imaging), and proton MR (magnetic resonance)
      spectroscopy in patients undergoing ECT for severe depression related to major depressive
      disorder (MDD) and bipolar disorder (BD). Subjects will undergo an MR imaging session of 1.5
      hrs duration at 3 time points: A) prior to initial ECT therapy; B) within 24 hrs following
      initial ECT therapy; C) 60-days following initial ECT therapy. Imaging measures will be
      correlated with clinical measures of disease severity at time points A and B in order to
      ascertain the potential utility of imaging biomarkers for prediction of therapy response. Our
      goal is to identify MR imaging biomarkers that may convey prognostic information which could
      be useful in the management of depression. Secondarily, the multi-modality MR imaging
      approach yielded functional connectivity data (both in the resting state and using an
      emotional regulation paradigm), white matter tract-based spatial statistics, and proton MR
      spectroscopy-derived metabolic information will facilitate an exploration of the physiologic
      mechanisms of ECT therapy. Twelve subjects will be recruited from a clinical population
      already diagnosed with a depressive episode requiring ECT. Patients will they be invited to
      participate in our study only after they have consented for ECT. Written consent will be
      obtained before any study procedures is conducted. Patients meeting any of the exclusion
      criteria will be excluded from participating in the study. Collected data will include: a)
      measures of depression severity (HAM-D, BDI) and b) multi-modality imaging data (fMRI,
      diffusion tensor imaging, proton MR spectroscopy, and anatomic MR imaging).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        No more than 20 patients will be enrolled for this study in order to obtain completion of
        the study by at least 10 participants. All inpatients with depression, 18 and older, who
        are referred for ECT treatment and consent for ECT treatments after a standard pre-ECT
        work-up will be considered potential participants for the study. The investigative team
        will discuss potential study participation with the primary treatment team.
      
Keywords: depression; electroconvulsive therapy (ECT); magnetic resonance imaging (MRI)