- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02044289
MR Imaging Biomarkers of Disease Response to ECT (Electroconvulsive Therapy) in Depression
February 2, 2016 updated by: University of Arkansas
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.
Study Overview
Status
Completed
Conditions
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).
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
60 days following initiation of therapy
|
Clinical response to ECT therapy as measured by the Beck Depression Inventory (BD)
Time Frame: 60 days following initiation of therapy
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assessment of depression by the previously validated BDI tool (score 0-63) (normal to severely depressed)
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60 days following initiation of therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ryan T Fitzgerald, MD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
January 21, 2014
First Submitted That Met QC Criteria
January 21, 2014
First Posted (Estimate)
January 23, 2014
Study Record Updates
Last Update Posted (Estimate)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202351
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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