MRI Studies of Emotion in Depression

NCT02429011 | Completed

• 2 other identifiers: GCO 10-13855K23MH094707
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

depression; MRI; treatment-resistant; imaging; ketamine

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale

  The Montgomery-Asberg Depression Rating Scale (74) is a well-validated 10-item instrument with good ecological validity. It is used extensively in clinical research for the evaluation of depressive symptoms in adults, and is particularly sensitive to detecting change in symptoms. This scale serves as the primary depression-related behavioral rating for correlation with our neuroimaging data.

  baseline and 24hrs post fMRI scan

Secondary Outcomes (2)

• Change in Clinician-Rated Inventory of Depressive Symptomatology (IDS-C30)

  baseline and 24hrs post fMRI scan

• Change in Brief Psychiatric Rating Scale and the Clinician-Administered Dissociative States Scale (CADSS)

  baseline and 24hrs post fMRI scan

Study Arms (2)

MDD

patients with current MDD

Healthy Control (HC)

healthy control volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research plan calls for the recruitment of adult human subjects with major depressive disorder (MDD) or healthy control (HC) volunteers over the 5-year grant period. All participants are required to be medically healthy as determined by medical history, physical examination, ECG, screening blood laboratory tests, urine analysis, and urine toxicology drug screen. Participants with MDD must have demonstrated inadequate therapeutic response to a minimum of one adequate antidepressant trial (e.g. TRD). MDD participants who meet this minimum TRD threshold will be eligible for the experiments in Aim 1. We recruit participants from several Mount Sinai-affiliated community hospitals (North General Hospital, Elmhurst), mental health associations (National Alliance for the Mentally Ill, Mood Disorders Support Group of New York), the Mood and Anxiety Disorders Program (MAP) Outpatient Clinic, the Mount Sinai Hospital outpatient psychiatry clinic, and from media/internet advertising.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• James Murrough, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: April 29, 2015
• Study Start: July 15, 2011
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (1)