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

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ClinicalTrials.gov Identifier: NCT02044289
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief 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.

Condition or disease
Depression

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).

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MR Imaging Biomarkers of Disease Response to ECT in Depression
Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical response to ECT therapy as measured by the HAM-D (Hamilton Rating Scale for Depression) [ Time Frame: 60 days following initiation of therapy ]
    clinical response will be measured by previously validated assessment tool (HAM-D); score 0-20 (normal to severely depressed)

  2. Clinical response to ECT therapy as measured by the Beck Depression Inventory (BD) [ Time Frame: 60 days following initiation of therapy ]
    assessment of depression by the previously validated BDI tool (score 0-63) (normal to severely depressed)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044289


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Ryan T Fitzgerald, MD University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02044289     History of Changes
Other Study ID Numbers: 202351
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by University of Arkansas:
depression
electroconvulsive therapy (ECT)
magnetic resonance imaging (MRI)
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders