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

NCT02044289 | Completed DMC

• 1 other identifier: 202351
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

depression; electroconvulsive therapy (ECT); magnetic resonance imaging (MRI)

Outcome Measures

Primary Outcomes (2)

• Clinical response to ECT therapy as measured by the HAM-D (Hamilton Rating Scale for Depression)

  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)

  assessment of depression by the previously validated BDI tool (score 0-63) (normal to severely depressed)

  60 days following initiation of therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ryan T Fitzgerald, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

US (1)