RECRUITING

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

Conditions

Healthy Major Depressive Disorder Treatment Resistant Depression depression ketamine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06480201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Julia Engelhardt

CONTACT

713-689-9856

julia.engelhardt@bcm.edu

Nicholas Murphy

CONTACT

713-798-7593

nicholas.murphy@bcm.edu

Study Locations (Sites)

Wells Medicine

Houston, Texas, 77024

United States

Baylor College of Medicine Jamail Specialty Care Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

depression
ketamine

Additional Relevant MeSH Terms

Healthy
Major Depressive Disorder
Treatment Resistant Depression