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NCT02429011 · ClinicalTrials.gov registry record
MRI Studies of Emotion in Depression
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 135
- Enrollment target
NCT02429011: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02429011 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 135 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02429011 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 135 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2011-07-15 |
| Est. Completion | 2016-05-31 |
What the finished NCT02429011 record still lists
NCT02429011 is an observational study that tracks outcomes without assigning an intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02429011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02429011 about?
NCT02429011 is a clinical study titled "MRI Studies of Emotion in Depression". 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 al...
What is the current status of trial NCT02429011?
This trial is currently completed. The enrollment target is 135 participants. The study started on 2011-07-15. Estimated completion is 2016-05-31.
Who is sponsoring clinical trial NCT02429011?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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