Major Depressive Disorder Clinical Trial
Official title:
Functional MRI Studies of Emotion in Depression and Rapid Antidepressant Response
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.
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).
o 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.
o 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.
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