Auditory MMN EEG in TRD in Response to Ketamine

Phase NA observational

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

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

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:
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

Start: 2022-10-03

End: 2024-12-31

Company

Product

Legal

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine infusion

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators