Electrophysiologic Mechanisms of Ketamine Antidepressant Response
Electrophysiologic Dynamics of Depression and Antidepressant Response in Epilepsy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Participants will receive a single intravenous ketamine infusion (0.5 mg/kg over 40 minutes) while hospitalized in the Epilepsy Monitoring Unit."
- "Research assessments will be completed before infusion and approximately 24 hours afterward."
- "Additional exploratory analyses will examine whether acute effects during infusion predict delayed responses observed 24 hours later."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at brain activity linked to how ketamine may ease depression. It is for adults with epilepsy and at least mild depression symptoms who are having sEEG, a test that records brain activity with electrodes placed inside the brain. Participants get one low-dose ketamine infusion through a vein, with brain recordings and behavior tests before and about 24 hours after treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are admitted to Emory’s Epilepsy Monitoring Unit for sEEG needed for your epilepsy care.
- You have at least mild depression symptoms: a score of 7 or higher on the MADRS or 14 or higher on the BDI-II depression survey.
- Your brain electrodes cover enough areas near the middle of the brain for the study.
- You can give informed consent and complete bedside tasks and surveys in English.
- You are expected to stay in the hospital for monitoring until about 24 hours after treatment, unless your care needs change.
Who can't join
- You have a documented IQ below 70, an intellectual disability, severe thinking or language problems, sudden confusion, or another condition that prevents consent or study tasks.
- You have or have had schizophrenia or another psychotic disorder, which can affect your sense of what is real.
- You currently have mania or hypomania—unusually high energy or mood—or a bipolar-related illness that the study doctor thinks could raise risk or affect results.
- You have had active alcohol or drug abuse or dependence within the past 3 months.
- You have an immediate risk of suicide or intend to act on suicidal thoughts and need urgent help. Thoughts without immediate intent may be reviewed individually, with psychiatric approval and extra monitoring.
- Ketamine is unsafe for you because of uncontrolled high blood pressure, unstable heart disease, a bulging or abnormal blood vessel, pregnancy, breastfeeding, or another serious unstable medical condition.
- Your care team thinks ketamine or the study timing would interfere with your epilepsy care or care around surgery.
- Sedatives or other medicines make ketamine unsafe or study tests unreliable, in your care team’s judgment. Participation may be delayed if this issue could resolve.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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).
Study sites (1)
GA
- Emory University · Atlanta, GA 30322Carl Hacker, MD, PhD · Study contact · 404-778-5770 · carl.hacker@emory.eduCarl Hacker, MD, PhD · Principal investigatorMore trials in Atlanta