Status:
RECRUITING
Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
The main purpose of this study is to investigate the effects of ketamine on decision-making and emotion processing in a sample of individuals diagnosed with Major Depressive Disorder (MDD).
Detailed Description
The main purpose of this study is to understand the effects of sub-anesthetic ketamine doses on varying functional domains of depression such as anhedonia, decision-making, and emotion processing in s...
Eligibility Criteria
Inclusion
- MDD Patients:
- willing and able to give written informed consent
- men or women, 18-65 years of age
- primary diagnosis of DSM-V MDD, current, as diagnosed by the SCID-I
- score of ≥20 on the Beck Depression Inventory, which will include patients characterized as having "moderate/severe" (20-28) or "very-severe" (29-63) depressive symptoms
- off all antidepressant therapy for at least 8 weeks prior to the baseline visit
- Healthy Controls:
- willing and able to give written informed consent
- men or women, 18-65 years of age
Exclusion
- MDD Patients:
- history of any bipolar disorder or psychotic disorder
- active psychotic symptoms of any type
- substance abuse/dependence within 6 months of study entry (as determined by SCID)
- unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination and laboratory testing), including upper respiratory disease or asthma, glaucoma or porphyria.
- active suicidal ideation as determined by a score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSR)
- use of any recreational drugs as confirmed by urine drug screen at the time of scanning
- pregnancy or lactation
- use of glucocorticoids at any time during the study
- Raynaud's disease that may interfere with the cold-pressor
- contraindications for MRI
- MMSE score \<28
- elevated blood pressure prior to infusion (systolic \> 160 or diastolic \>100)
- history of treatment resistance as determined by ATRQ
- prior adverse reaction to ketamine
- use of antipsychotic medications
- use of greater than 2mg daily of lorazepam or similar benzodiazipine.
- Regular smoker as self-reported
- Healthy Controls:
- evidence of any psychiatric disorder with exception of specific phobia, and no history of any psychiatric disorder except mild past substance use disorder as diagnosed by the SCID-I
- history of any substance abuse within the last 6 months
- use of any recreational drugs as confirmed by urine drug screen at the time of scanning
- pregnancy or lactation
- use of glucocorticoids at any time during the study
- Raynaud's disease that may interfere with the cold-pressor
- contraindications for MRI
- MMSE score \<28
- Regular smoker as self-reported
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05327699
Start Date
November 8 2022
End Date
December 31 2026
Last Update
April 20 2025
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322