Glutamatergic Adaptation to Stress as a Mechanism... — Clinical Trial Details

This study evaluates the glutamate stress response and its relation to motivation, valuation, and anhedonia in people with Major Depressive Disorder using multimodal neuroimaging, behavioural tasks, and questionnaires.

MDD participants are randomized to a single IV ketamine infusion (0.5 mg/kg) or saline placebo administered over 40–100 minutes; behavioural and imaging assessments are collected to measure acute and downstream effects.

A separate healthy control cohort (n≈60) completes a behavioural session and one neuroimaging session for baseline comparison and does not receive any intervention.

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
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
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 benzodiazepine
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

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Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine

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Study Arms & Interventions

Ketamine

Interventions

Placebo

Interventions

Healthy controls

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Inclusion Criteria

Exclusion Criteria

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