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CompletedN/A

MRI Studies of Emotion in Depression

NCT02429011 · Icahn School of Medicine at Mount Sinai

Closed to entry
Status
Not accepting participants
Not applicable
Phase
135
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The purpose of this study is to research the effects of ketamine on brain function in patients with Major Depressive Disorder (MDD). This study is an ancillary MRI neuroimaging study being conducted in patients with MDD who are enrolled in a separate clinical trial. Healthy control volunteers are also enrolled. No drug or other intervention is given as part of this protocol per se. To study brain activity related to emotion, the study team will use a technology called functional MRI (fMRI), which is a method for evaluating the flow of blood in the brain using a powerful magnet. fMRI does not involve exposure to radiation. Patients will be shown a sample of images on a computer screen designed to bring about an emotional reaction. The MRI machine will then take a number of pictures of your head. By computer analysis, this machine is able to create a picture of your brain's activity. There are several tasks during scanning that involve looking at various images that represent different emotions, and the study team will be monitoring brain activity during these tasks. Patients will be scanned before and 24 hours after receiving ketamine (as part of a separate study) to analyze treatments effects. These scans are compared to depressed patients who did not receive ketamine, as well as to healthy controls.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Montgomery-Asberg Depression Rating Scale

    Measured over baseline and 24hrs post fMRI scan

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Male or female participants, 18-70 years of age; * Participants must be free of any psychiatric condition (for the healthy volunteer group) or meet DSM-IV criteria for major depressive disorder, without psychotic features, based on the Structured Clinical Interview for DSM-IV TR Axis I Disorders (SCID); * Participants have demonstrated inadequate response to a minimum of 1 adequate antidepressant treatment trial in current episode (e.g. TRD); * Participants must be willing to undergo washout of psychotropic medications that he or she is taking; * Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process. Exclusion Criteria: * Lifetime diagnosis of schizophrenia or any psychotic disorder, bipolar disorder, pervasive developmental disorders or mental retardation; * Current diagnosis of obsessive-compulsive disorder (OCD), but not other anxiety disorders; * Diagnosis of a substance use disorder within the past six months; all participants must have a negative urine toxicology test on the day of the fMRI, prior to the scan; * Female participants who are pregnant, nursing, for may become pregnant; * Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease; * Clinically significant abnormalities of laboratories, physical examination, or ECG; * Participants judged to be at serious suicidal risk by the PI or another study-affiliated psychiatrist; * Any contraindications to MRI, including pacemakers or metallic objects in the body.

Where

1 study site

FacilityCityRegionCountry
Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02429011 on ClinicalTrials.gov →

Last updated in the registry 2017-04-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits