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RecruitingEarly Phase 1

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

NCT05327699 · Emory University

Recruiting
Status
Accepting participants
Early Phase 1
Phase
140
Target enrolment
1
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in glutamate concentration in the medial prefrontal cortex (mPFC)

    Measured over Baseline, 24 hours post-infusion, 14 days post-infusion

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Emory UniversityAtlantaGeorgiaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05327699 on ClinicalTrials.gov →

Last updated in the registry 2026-05-26. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits