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

Part of paid clinical trials in Houston, Texas.

Sponsor
Texas A&M University
Study ID
NCT06480201
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Ketamine — DRUG
    Ketamine infusion amount is dictated by BMI, sex, and age.
  • Saline — OTHER
    Saline infusion amount is dictated by BMI, sex, and age.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Healthy Controls
    Healthy controls will receive one saline and ketamine infusion.
  • Active Comparator: Major Depressive Disorder
    Major Depressive Disorder participants will receive one saline and ketamine infusion.
  • Active Comparator: Treatment Resistant Depression
    Treatment Resistant Depression participants will receive 8 ketamine infusions where their first and fourth infusions are a saline and ketamine infusion.

Primary Outcome Measure

Resting State Gamma Power [ Time Frame: Before infusion, during infusion, 60-90 minutes after infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Texas A&M (Houston Methodist Hospital Location)HoustonTexas77030
Nicholas Murphy
[email protected]
713-798-7593
Sanjay Mathew
[email protected]
7137985877
Wells MedicineHoustonTexas77024
Jesse Wells
[email protected]
(713) 589-5118

Find similar trials in Houston, TX

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Texas A&M (Houston Methodist Hospital Location)· Houston, TXWells Medicine· Houston, TX

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