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Electrophysiologic Mechanisms of Ketamine Antidepressant Response

ConditionsEpilepsyDepressive Symptoms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ketamine

    Drug

    Participants will receive one subanesthetic intravenous ketamine infusion administered at a dose of 0.5 mg/kg over 40 minutes during admission to the Epilepsy Monitoring Unit. The infusion will be supervised by a psychiatrist experienced in ketamine administration and conducted under continuous clinical monitoring. Intracranial sEEG recordings, behavioral assessments, and symptom measures collected before and approximately 24 hours after infusion will be used to evaluate electrophysiologic biomarkers associated with antidepressant response

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Intravenous Ketamine During sEEG MonitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Prefrontal-Posterior Brain Connectivity

This outcome measures intracranial electrophysiologic connectivity between prefrontal and posterior midline brain regions, calculated from gamma-band neural activity.

Time frame
Baseline and approximately 24 hours post-ketamine infusion
2

Change in Prefrontal Cortical Excitability Measure

This outcome measures local cortical excitability using a spectral measure derived from intracranial electrophysiologic recordings in prefrontal brain regions.

Time frame
Baseline (pre-infusion) and approximately 24 hours post-ketamine infusion.

Secondary outcomes

1

Change in Thought Content Task Score

This outcome measures a task-based measure of the emotional content of participants' self-generated thoughts, reflecting positive versus negative thought bias.

Time frame
Baseline and approximately 24 hours post-ketamine infusion.
2

Association Between Change in Prefrontal-Posterior Brain Connectivity and Change in Thought Content Task Score

This outcome evaluates whether change in prefrontal-posterior brain connectivity is associated with change in the thought content task score.

Time frame
Baseline and approximately 24 hours post-ketamine infusion.
3

Change in Hedonic Capacity Score

This outcome measures a validated self-report measure of hedonic capacity, or the ability to experience pleasure.

Time frame
Baseline and approximately 24 hours post-ketamine infusion.
4

Association Between Change in Prefrontal Cortical Excitability and Change in Hedonic Capacity Score

This outcome evaluates whether a change in the prefrontal cortical excitability measure is associated with a change in the hedonic capacity score.

Time frame
Baseline and approximately 24 hours post-ketamine infusion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: