RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Ketamine for Healthy

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.

Official registry: https://clinicaltrials.gov/study/NCT06480201 · Texas A&M University · enrollment listed as 100

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Ketamine, or Saline. The registry lists allocation as randomized. 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.

They plan to enroll about 100 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Ketamine, Saline

Primary outcome (registry wording): Resting State Gamma Power

Who it is for (from inclusion criteria)

Ages 21 Years to 45 Years
All subjects who can join:
Male or Female ages 21-45, inclusive
Level of understanding sufficient to agree to all tests and examinations required by the protocol
Major depressive disorder (major depression) 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

Who the registry excludes

History of major depression 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
Pregnancy or Breast-feeding. All female participants in reproductive age will undergo pregnancy tests. Female you would be required to provide evidence of use of contraceptives during the course of the study
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
Previous exposure to ketamine or esketamine
Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to screening

Public study contact (from the registry)

Julia Engelhardt

7136777595

epmadlab@tamu.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Wells Medicine — Houston, Texas (recruiting)
Texas A&M (Houston Methodist Hospital Location) — Houston, Texas (recruiting)

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FAQ about this NCT record

Is NCT06480201 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06480201?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06480201?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary