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Not yet recruitingPhase 2

Electrophysiologic Mechanisms of Ketamine Antidepressant Response

NCT07768618 · Ketamine-sEEG · Emory University

Closed to entry
Status
Not accepting participants
Phase 2
Phase
37
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study aims to identify electrophysiologic biomarkers associated with antidepressant response to ketamine in adults with epilepsy undergoing clinically indicated stereo-electroencephalography (sEEG) monitoring who have at least mild depressive symptoms. Participants will receive a single subanesthetic intravenous ketamine infusion (0.5 mg/kg over 40 minutes) during their Epilepsy Monitoring Unit admission. Intracranial neural recordings and behavioral assessments will be collected before and approximately 24 hours after infusion to examine changes in neural circuits associated with rumination and anhedonia.

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 Prefrontal-Posterior Brain Connectivity

    Measured over Baseline and approximately 24 hours post-ketamine infusion

  • Change in Prefrontal Cortical Excitability Measure

    Measured over Baseline (pre-infusion) and approximately 24 hours post-ketamine 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
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Admitted to the Emory EMU for clinically indicated sEEG monitoring for epilepsy. * At least mild depressive symptoms at baseline, defined as MADRS ≥7 or BDI-II ≥14. * Electrode coverage that includes midline regions sufficient for enrollment and analyses. * Ability to provide informed consent and to complete bedside tasks/questionnaires in English. * Expected to remain under inpatient monitoring through the planned \~24-hour post-infusion follow-up unless clinical needs dictate otherwise. Exclusion Criteria: * Documented IQ \<70, intellectual disability, severe cognitive impairment, delirium, severe aphasia, or other condition that prevents valid consent or task participation. * Current or past schizophrenia-spectrum disorder or other psychotic disorder. * Current manic/hypomanic episode or bipolar-spectrum illness judged by study psychiatrist/investigator to increase risk or confound interpretation. * Active alcohol or substance abuse/dependence within the past 3 months. * Imminent suicide risk or active suicidal intent requiring urgent intervention as determined by clinical assessment. Passive ideation without imminent intent may be considered on a case-by-case basis with psychiatric approval and enhanced monitoring. * Contraindication to subanesthetic ketamine, including uncontrolled hypertension, unstable cardiovascular disease, aneurysm/vascular malformation or similar condition conferring unacceptable risk, pregnancy, breastfeeding, or other clinically significant medical instability. * Clinical team determination that ketamine administration or study timing would interfere with epilepsy care or perioperative management. * Sedative or other medication exposure at a level that, in the judgment of the clinical team, precludes safe ketamine administration or reliable behavioral assessment (participant may be deferred rather than permanently excluded if the issue resolves).

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.

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NCT07768618 on ClinicalTrials.gov →

Last updated in the registry 2026-08-17. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits