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Ketamine and Gamma Oscillations for Treatment-Resistant Depression

This study is looking at how ketamine, a medication, affects brain activity in people with treatment-resistant depression (depression that hasn't responded to other treatments). Researchers want to see if changes in a specific type of brain wave, called gamma oscillations (measured with an EEG, a test that records brain activity), can predict how well ketamine will work to improve depression symptoms over four weeks. You might receive either ketamine or saline (saltwater, used as a comparison) through an infusion. The study aims to understand if these brain wave changes can serve as a "prognostic marker," meaning something that helps doctors predict treatment success. The study plans to enroll 100 participants between 21 and 45 years old.

Study design
This is an interventional study with 100 planned participants, but the specific phase is not mentioned. It involves giving participants either ketamine or saline infusions.
What's involved
You would have brain activity measurements (EEG) before, during, and after the infusion. Your depression symptoms would also be assessed at the start, before infusion, and up to a month after the infusion.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be assessed up to a month after the infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06480201

Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression

Recruiting
PHASE1Ages 21–45Interventional
Texas A&M University
~100 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:KetamineSaline

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resting State Gamma Power
Measured over Before infusion, during infusion, 60-90 minutes after infusion
+2 more outcomes measured

Conditions

Healthy
Major Depressive Disorder
Treatment Resistant Depression

Explore related trials

Treatment resistant depressionUnipolar Depression

Where it's being run

2 sites across 1 states
Texas2

Who to contact

Julia Engelhardt
[email protected]
713-689-9856
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

The criteria for eligibility described here are intended to protect patient welfare where, for example, the administration of ketamine in the context of standardized research (i.e. pharmaco-EEG challenge) would be inadvisable or unsafe. An additional purpose is to decrease psychiatric co-morbidities that may affect the clinical phenomenology or treatment response and thus obscure findings. Further, by virtue of the eligibility criteria the investigators seek to limit variability due to demographic and other factors.
Male or Female ages 21-45, inclusive.
Level of understanding sufficient to agree to all tests and examinations required by the protocol. 3. TRD patients
Major depressive disorder (MDD) diagnosis confirmed by MINI, with major depressive episode of at least 4 weeks duration.
MADRS score of 27 or greater.
Meet criteria for treatment resistance, defined as 2+ unsuccessful trials of antidepressants at an adequate dose for at least 6 weeks.
On a stable dose of all psychotropic medications (including antidepressant, antipsychotic, lithium, hypnotic, etc) for a minimum of 4 weeks prior to the Screening period. 4. MDD patients
MDD diagnosis confirmed by the Mini International Neuropsychiatric Interview (MINI), with major depressive episode of at least 4 weeks duration.
MADRS score of less than or equal to 12.
On a stable dose of all psychotropic medications (including antidepressant, antipsychotic, lithium, hypnotic, etc) for a minimum of 4 weeks prior to the Screening period.

Exclusion

History of MDD with psychotic features, bipolar disorder, schizophrenia spectrum and other psychotic disorders, currently exhibiting psychotic features, or a first-degree relative with a psychotic disorder.
Diagnosed with intellectual disability.
Current major medical problems that affect brain anatomy, neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, (unstable Arrhythmias, Chronic Heart Failure, Myocardial Infarction (MI) cardiac pacemaker), systemic infections, cancer, active upper respiratory infections, respiratory depression and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases), and head injury with loss of consciousness for any period of time.
Pregnancy or Breast-feeding. All female participants in reproductive age will undergo pregnancy tests. Female participants will be required to provide evidence of use of contraceptives during the course of the study.
Unable to understand the design and requirements of the study.
Unable to sign the informed consent for any reason.
Patients with a severe personality disorder, including risk for homicide or aggressive behavior, which in the opinion of the investigator has a major impact on the patients' current psychiatric status and would preclude safe study participation.
Patients at serious and imminent risk of suicide and not suitable for an outpatient study, in the judgment of the investigators.
Patients taking medications with known activity at the N-methyl-D-aspartate (NMDA) or α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA) glutamate receptor \[eg, riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, D-cycloserine\], or the mu-opioid receptor.
Previous exposure to ketamine or esketamine.
Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to screening.
Patients with no regular contact with at least one adult. Patients who are un-domiciled are excluded.
Body mass index (BMI) \>=40 kg/m2.
Active eating disorder or cognitive deficit affecting the regulation of food intake.
Current or recent course of electroconvulsive therapy (ECT) (past month).
History of deep brain stimulation (DBS), vagal nerve stimulation (VNS) implantation, or other form of psychosurgery
Recently started cognitive behavioral therapy (CBT) (past month).
Patients taking \>6mg/day lorazepam (benzodiazepine)-equivalents. Patients with lower and/or infrequent use of benzodiazepines will be required to discontinue their dose on the morning (noting that this is already per protocol at the partner ketamine clinic).
Patients taking prescription opioids. Over the counter pain medications are proscribed on infusion days.
Dietary supplements affecting central nervous system (CNS) function will be discontinued before the study start. This will include supplementation of glutamate, serotonin (e.g. 5-hydroxytryptophan(HTP), St. John's Wort), creatine, γ-Aminobutyric acid (GABA).
Patients habitually consuming legal cannabis products containing cannabidiol (CBD) or delta-8-tetrahydrocannabinol (THC).
The participant has a known ketamine allergy or is taking any medication that may interact with ketamine.

What this trial measures

  • Resting State Gamma PowerBefore infusion, during infusion, 60-90 minutes after infusion

    Gamma power is the resting state electroencephalogram represents the amplitude of oscillations measuring the in the 30+ hertz (Hz) range of the power-spectrum. This is used as a proxy measure of the level of cortical disinhibition occurring at rest.

  • Auditory Steady State Response Gamma PowerBefore infusion, during infusion, 60-90 minutes after infusion

    Auditory Steady State Response gamma power represents the entrainment of inhibitory interneurons in response to a train of short tones, resembling a high frequency click, that are presented for a 1000ms at a rate of 40 Hz.

  • Montgomery-Asberg Depression Rating Scale (MADRS)Study entry, pre-infusion, study exit visit (up to a month after infusion)

    The MADRS is a clinician administered rating scale consisting of 10 items to measure depression symptom severity. Each item has a rating scale of 0-6. Greater total scores indicate more severe depression.