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Official title Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression
ClinicalTrials.gov ID: NCT06480201
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 45. Healthy volunteers may be eligible.
You may be able to join if
- General
- The criteria for eligibility described here are intended to protect patient welfare where, for example, the administration of ketamine in the context...
- All people
- Male or Female ages 21-45, inclusive.
- Level of understanding sufficient to agree to all tests and examinations required by the protocol.
You likely can't join if
- History of MDD with psychotic features, bipolar disorder, schizophrenia spectrum and other psychotic disorders, currently exhibiting psychotic...
- Diagnosed with intellectual disability.
- Current major medical problems that affect brain anatomy, neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency...
- Pregnancy or Breast-feeding. All female participants in reproductive age will undergo pregnancy tests. Female participants will be required to...
- Unable to understand the design and requirements of the study.
- Unable to sign the informed consent for any reason.
See the full eligibility criteria
- 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...
- All people
- Male or Female ages 21-45, inclusive.
- Level of understanding sufficient to agree to all tests and examinations required by the protocol.
- 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.
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.