Trials / Completed
CompletedNCT02044289
MR Imaging Biomarkers of Disease Response to ECT (Electroconvulsive Therapy) in Depression
MR Imaging Biomarkers of Disease Response to ECT in Depression
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- University of Arkansas · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2014-01-23
- Last updated
- 2016-02-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02044289. Inclusion in this directory is not an endorsement.