Major Depressive DisorderNCT02429011

MRI Studies of Emotion in Depression

An observational study of Major Depressive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
How many people: 135 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2011to 31 May 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: Functional MRI Studies of Emotion in Depression and Rapid Antidepressant Response

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.

Read the detailed description

Specific Aim 1: To characterize the function of basic neural systems involved in emotion perception and regulation in TRD.

Experiment 1.1: Neural responses to emotional faces in TRD (neutral, low and high intensity sad facial expressions).
Hypothesis 1.1: Patients with TRD, relative to HC participants, will evidence increased activation in the amygdala/parahippocampal gyrus to sad compared to neutral faces.
Experiment 1.2: Neural responses during negative emotion regulation in TRD (cognitive reappraisal).
Hypothesis 1.2: Patients with TRD, relative to HC participants, will show enhanced activation of the amygdala during the generation of negative affect and will be impaired in their ability to recruit PFC/ACC regions during attempts to down-regulate negative affect.

Specific Aim 2: To characterize changes in emotion-processing neural networks associated with ketamine and rapid antidepressant response.

Experiment 2.1: Neural changes in response to emotional faces associated with ketamine and rapid antidepressant response.
Hypothesis 2.1a: Ketamine, compared to midazolam, will be associated with reduced activation in the amygdala to sad compared to neutral faces. 2.1b: Antidepressant response, compared to non-response, will be specifically associated with changes in PFC/ACC function.
Experiment 2.2: Neural changes during negative emotion regulation (cognitive reappraisal) associated with ketamine and rapid antidepressant response.
Hypothesis 2.2a: Ketamine, compared to midazolam, will be associated with reduced activation in the amygdala during negative emotion generation and enhanced PFC/ACC function during down-regulation of negative affect. 2.2b: Antidepressant response, compared to non-response, will be specifically associated with enhancement of PFC/ACC function.

Specific Aim 3 (Exploratory): To investigate functional and effective connectivity between emotion perception/generation neural systems and cognitive emotional regulation systems. Hypothesis 3: TRD compared to HC will be characterized by abnormal connectivity between PFC/ACC and amygdala, which will normalize with rapid antidepressant response.

The setting of research will be MSSM. All research participants will be recruited and screened through the Mood and Anxiety Disorders Program (MAP) (Director: Dan V. Iosifescu, M.D.) at MSSM. MAP is one of the major clinical research programs of the Department of Psychiatry, with research funding from NIH, the Department of Defense, NARSAD, and industry.

Conditions: Major Depressive Disorder
Keywords: depression, MRI, treatment-resistant, imaging, ketamine
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02429011
Study group	Role	What they receive
MDD		patients with current MDD
Healthy Control (HC)		healthy control volunteers

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline and 24hrs post fMRI scan

Secondary outcomes (2)

Change in Clinician-Rated Inventory of Depressive Symptomatology (IDS-C30)
The 30-item Clinician-Rated Inventory of Depressive Symptomatology (IDS-C30) (75) is a clinician-rated instrument which includes all DSM-IV diagnostic criterion items for MDD as well as commonly associated symptoms such as anxiety, irritability, and melancholic and atypical symptom features.
Measured: baseline and 24hrs post fMRI scan
Change in Brief Psychiatric Rating Scale and the Clinician-Administered Dissociative States Scale (CADSS)
Potential dissociative or other acute behavioral changes during the KET/MID infusions will be assessed using the Brief Psychiatric Rating Scale and the Clinician-Administered Dissociative States Scale (CADSS)
Measured: baseline and 24hrs post fMRI scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201131 May 2016

First posted29 Apr 2015 (estimated)
Study start15 Jul 2011
Primary completion31 May 2016
Study completion31 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02429011
Sponsor's protocol ID: GCO 10-1385
Other IDs: 5K23MH094707
Status last verified: Apr 2017
First submitted: 24 Apr 2015
Last updated: 6 Apr 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional MRI Studies of Emotion in Depression and Rapid Antidepressant Response
ClinicalTrials.gov ID: NCT02429011
Acronym / sponsor ID: GCO 10-1385
Conditions: Major Depressive Disorder
Keywords: depression, MRI, treatment-resistant, imaging, ketamine
Study type: Observational
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 15 Jul 2011 (actual)
Primary completion: 31 May 2016 (actual)
Study completion: 31 May 2016 (actual)
First posted: 29 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aim 1: To characterize the function of basic neural systems involved in emotion perception and regulation in TRD.

Experiment 1.1: Neural responses to emotional faces in TRD (neutral, low and high intensity sad facial expressions).
Hypothesis 1.1: Patients with TRD, relative to HC participants, will evidence increased activation in the amygdala/parahippocampal gyrus to sad compared to neutral faces.
Experiment 1.2: Neural responses during negative emotion regulation in TRD (cognitive reappraisal).
Hypothesis 1.2: Patients with TRD, relative to HC participants, will show enhanced activation of the amygdala during the generation of negative affect and will be impaired in their ability to recruit PFC/ACC regions during attempts to down-regulate negative affect.

Specific Aim 2: To characterize changes in emotion-processing neural networks associated with ketamine and rapid antidepressant response.

Experiment 2.1: Neural changes in response to emotional faces associated with ketamine and rapid antidepressant response.
Hypothesis 2.1a: Ketamine, compared to midazolam, will be associated with reduced activation in the amygdala to sad compared to neutral faces. 2.1b: Antidepressant response, compared to non-response, will be specifically associated with changes in PFC/ACC function.
Experiment 2.2: Neural changes during negative emotion regulation (cognitive reappraisal) associated with ketamine and rapid antidepressant response.
Hypothesis 2.2a: Ketamine, compared to midazolam, will be associated with reduced activation in the amygdala during negative emotion generation and enhanced PFC/ACC function during down-regulation of negative affect. 2.2b: Antidepressant response, compared to non-response, will be specifically associated with enhancement of PFC/ACC function.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
MDD	–	–patients with current MDD
Healthy Control (HC)	–	–healthy control volunteers

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in Montgomery-Asberg Depression Rating Scale
Time frame: baseline and 24hrs post fMRI scan
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.

2 secondary outcomes

Change in Clinician-Rated Inventory of Depressive Symptomatology (IDS-C30)
Time frame: baseline and 24hrs post fMRI scan
Change in Brief Psychiatric Rating Scale and the Clinician-Administered Dissociative States Scale (CADSS)
Time frame: baseline and 24hrs post fMRI scan

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.

Related trials for Major Depressive Disorder

RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
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RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Murrough, MD principal investigator

Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery-Asberg Depression Rating Scale (time frame: baseline and 24hrs post fMRI scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02429011.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.