Using EEG to predict ketamine treatment response in patients with treatment-resistant depression
Deciphering Metacognition and Treatment Response in Depression With a Novel Digital Paradigm
This study is testing if brain activity measured by EEG can help predict how well people with treatment-resistant depression will respond to ketamine treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05464264 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and test a neurocomputational model that predicts how patients with treatment-resistant depression (TRD) will respond to ketamine treatment. By applying a validated computational model of the mismatch negativity (MMN) and examining the effects of NMDAR antagonism, the study seeks to differentiate between ketamine's antisuicidal effects and its mood improvement effects. The research includes two main goals: understanding the computational mechanisms that predict treatment response and linking these mechanisms to their neural causes using circuit models. The findings may enable personalized treatment predictions based on EEG recordings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with treatment-resistant depression who have failed at least two antidepressant therapies.
Not a fit: Patients with a history of bipolar disorder, psychosis, or current substance use issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide individualized prognostic insights for patients undergoing ketamine treatment for depression.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in using EEG and computational models to predict treatment responses, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.18 to 65 years of age 2. Meeting Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for MDD and in a Major Depressive Episode and ≥10 on the Montgomery-Asberg Depression Rating Scale (MADRS). 3. Competent to consent-based on their 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.
Where this trial is running
Toronto, Ontario
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Venkat Bhat, MD MSc
- Email: Venkat.Bhat@unityhealth.to
- Phone: 416-360-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.