RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 45 Years
Sex
All sexes
Healthy volunteers
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
  • "Treatment of depression via the rapid acting modulation of neural circuitry is at a critical stage of development with strategies such as ketamine (KET) infusion, esketamine nasal spray, and intermittent theta burst stimulation making substantial progress."
  • "Theoretically, the process of gamma band potentiation (GBP) by ketamine represents the capacity of the brain to up-regulate glutamatergic activity in response to the initial infusion."
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 tests whether changes in brain waves after ketamine can predict how much depression improves after 4 weeks. An EEG, a test that records brain activity, measures these waves. The study includes adults ages 21–45 with depression that has not improved with treatment, and another group with major depression and low current symptom scores.

The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (GBP) in the context of a single infusion. Our study design captures the clinical variation associated with real-world treatment resistant depression (TRD) patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment. If successful, it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 21–45 years old.
  • Be able to understand and agree to all required study tests and exams.
  • Have major depression confirmed by a study interview, with a depression episode lasting at least 4 weeks.
  • For the treatment-resistant group: have a score of 27 or higher on the MADRS, a scale that measures depression symptoms.
  • For the treatment-resistant group: have tried at least 2 antidepressants that did not work, each at a suitable dose for at least 6 weeks.
  • For the other depression group: have a MADRS depression score of 12 or lower.
  • Have no dose changes in medicines for mental health or sleep for at least 4 weeks before screening.

Who can't join

  • Certain mental health conditions: bipolar disorder, disorders involving loss of touch with reality, depression with those symptoms, or a parent, sibling, or child with a psychotic disorder. Intellectual disability, a severe personality disorder that makes joining unsafe, or an immediate serious suicide risk also rule out joining.
  • Major health problems affecting the brain or body, including listed heart, liver, kidney, breathing, infection, cancer, or brain conditions; or any head injury that caused loss of consciousness.
  • Pregnancy or breastfeeding. Women who can become pregnant must take pregnancy tests and show that they use birth control. Starting hormone treatment within 3 months before screening also rules out joining.
  • Past ketamine or esketamine use, a ketamine allergy, or medicines that may interact with ketamine. Certain medicines acting on brain glutamate or opioid receptors, prescription opioids, and high doses of calming medicines also rule out joining.
  • ECT, a treatment using electrical pulses, or newly started cognitive behavioral therapy within the past month; or a history of implanted brain or vagus nerve stimulators or brain surgery for mental illness.
  • A BMI of 40 or higher, a measure of weight compared with height; an active eating disorder; or thinking problems that affect control of eating.
  • Regular use of cannabis products containing CBD or delta-8 THC. Supplements that affect the brain must be stopped before the study. Nonprescription pain medicines are not allowed on infusion days, and allowed lower doses of calming medicines must be skipped that morning.
  • Being unable to understand the study or sign the consent form, having no regular contact with at least one adult, or having no home.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. General * 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. 2. All subjects Inclusion Criteria: * 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 Criteria: * 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.

Study sites (2)

TX