Actively Recruiting
Neural Circuit Effects of Ketamine in Depression
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-07-03
120
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This project is designed to examine the role of the subgenual anterior cingulate cortex (sgACC) in anhedonia and anxiety in humans with depression, as well as the acute and sustained effects of ketamine on agACC activation and depression symptoms.
CONDITIONS
Official Title
Neural Circuit Effects of Ketamine in Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Ability to comply with study requirements as determined by the investigator
- Capacity to provide informed consent
- For MDD group: meet diagnostic criteria for current major depressive disorder according to DSM-5
- For MDD group: currently experiencing a major depressive episode of at least moderate severity
- Women of childbearing potential must use reliable contraception and have a negative pregnancy test before infusion
- Women not of childbearing potential include those surgically sterile or postmenopausal for at least one year
You will not qualify if you...
- For MDD group: history or current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, neurodevelopmental or neurocognitive disorder
- For MDD group: major depressive disorder with psychotic features
- Substance use disorder within past 2 years
- Lifetime history of ketamine use disorder
- Use of antidepressant medication within 2 weeks of baseline (4 weeks for fluoxetine)
- Severe current illness (CGI score >5)
- Unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic diseases
- Clinically significant abnormal labs, physical exam, or ECG
- Positive urine drug screen at screening except cannabis
- Women who are pregnant, planning pregnancy, or breastfeeding
- Active suicidal intent or plan with CSSRS score >2
- Any MRI contraindications such as claustrophobia, magnetic implants, or inability to lie still for 1 hour
- Any condition compromising safety or data quality as judged by the investigator
- For healthy control group: any psychiatric, neurodevelopmental, or neurocognitive disorder
- Current pregnancy or breastfeeding in healthy controls
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
Sibilla Masieri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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