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Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine
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).
ClinicalTrials.gov IDNCT05327699
PhaseEARLY_PHASE1
Enrollment140
SponsorEmory University
Age18 Years
SexALL
Conditions studied
Major Depressive Disorder
About this study
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).
Interventions
- Drug: Ketamine — A single intravenous (IV) infusion of ketamine calculated at 0.5mg/kg through an indwelling catheter over a 40-100min period.
- Other: Placebo — A single intravenous (IV) infusion of saline through an indwelling catheter over a 40-100min period.
Primary outcomes
- Change in glutamate concentration in the medial prefrontal cortex (mPFC) (Baseline, 24 hours post-infusion, 14 days post-infusion)
Eligibility information
Inclusion Criteria:
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 Criteria:
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
Study locations
- Emory University, Atlanta, Georgia 30322 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.