Clinical TrialTreatment-Resistant Depression (TRD)KetamineUnknown status

Auditory MMN EEG in TRD in Response to Ketamine

This observational trial (n=30) will investigate the neurocomputational model of ketamine treatment response predictions in treatment-resistant depression (TRD).

Target Enrollment
30 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

The study applies a validated computational model of the auditory mismatch negativity (MMN) to predict treatment response to clinical ketamine infusions in patients with treatment-resistant depression.

Participants receiving standard-of-care IV ketamine (0.5 mg/kg over 40 minutes, twice weekly for two weeks) will have EEG MMN recordings fitted to neural and circuit models to identify computational markers that predict clinical and antisuicidal response.

If successful, model-derived parameters from noninvasive EEG could enable single-patient prognostic statements to guide clinical decision-making for ketamine treatment in TRD.

Study Protocol

Preparation

sessions

Dosing

4 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine infusion

experimental

Clinical ketamine treatment as delivered in the interventional psychiatry programme: IV infusions twice weekly for two weeks (4 treatments).

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly• 4 doses total

    Infused over 40 minutes; dose adjustments at psychiatrist's discretion.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. 18 to 65 years of age
  • 2. Meeting DSM-5 criteria for Major Depressive Disorder and currently in a Major Depressive Episode and ≥10 on the MADRS
  • 3. Competent to consent based on ability to provide a spontaneous narrative description of the key elements of the study
  • 4. Failure of at least two trials of antidepressant therapy during the current episode (treatment-resistant depression) and receiving ketamine treatment clinically as administered by their clinician
  • 5. Staying on stable dosages of any concomitant psychotropic medications.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. History of bipolar disorder or psychosis
  • 2. Current substance use or history of substance use during the past year (excluding nicotine and caffeine use disorder)
  • 3. Concomitant major and unstable medical or neurologic illness or a history of seizures
  • 4. Non-English-speaking individuals

Study Details

Locations

St. Michael's Hospital — Toronto, Ontario, Canada

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