MR Imaging Biomarkers of Disease Response to ECT (Electroconvulsive Therapy) in Depression



Status:Completed
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 100
Updated:4/21/2016
Start Date:June 2014
End Date:December 2015

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MR Imaging Biomarkers of Disease Response to ECT in Depression

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.

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).

Inclusion Criteria:

- Men and women ages 18 and older

- Diagnosis of major depressive disorder based on the SCID

- Score of 20 or more on the HAM-D at enrollment

- Ability to provide informed consent

- Referral for ECT, clinical assessment (health screening, i.e. "work-up") confirming
suitability of receiving ECT, and consent to receive ECT

- Ability to speak English (necessary for SCID) and an 8th grade English reading
equivalency (necessary for completing assessment forms)

Exclusion Criteria:

- Claustrophobia, or the inability to lie still in a confined space

- Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips,
artificial heart valves, inner ear (cochlear) implants, artificial joints, and
vascular stents), as these may heat, pull, or twist in the strong magnetic field of
the MRI scanner

- Electronic or magnetic implants, such as pacemakers, as these may stop working

- Non-removable dental implants, such as braces or permanent retainers, as these will
distort the MRI images we collect (note: filings, crowns, and silver or gold teeth
are OK)

- Permanent makeup or tattoos with metallic dyes

- Self-report of pregnancy at intake

- A positive pregnancy test (for females), since the effect of strong magnetic fields
on the developing fetus remains unknown and inconclusive. (We will conduct a
pregnancy test for all female participants on the day of the MRI scan.)

- A self-reported history of loss of consciousness (greater than 10 minutes)

- Physical disabilities that prohibit task performance (such as blindness or deafness)

- Any other condition that the investigator believes might put the participant at risk
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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mi
from
Little Rock, AR
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