Auditory MMN EEG in TRD in Response to Ketamine

Recruiting

• Conditions: Treatment-resistant Depression (TRD)

• Registration Number: NCT05464264
• Lead Sponsor: Unity Health Toronto

Brief Summary

To develop and test a neurocomputational model of ketamine treatment response predictions in TRD.

Detailed Description

The investigators propose applying a previously validated computational model of the MMN and the ensuing effects of NMDAR antagonism to predict treatment response following ketamine infusions in TRD patients and distinguish ketamine's antisuicidal effects from those related to mood improvements. The study has two subgoals: first, the computational mechanisms underlying MMN reductions that predict ketamine treatment response in TRD patients will be examined. Second, the computational mechanisms will be linked to their underlying neural causes using neural circuit models. Beyond understanding ketamine's short- and long-term mechanisms of action in TRD, the parameters obtained from fitting these models to noninvasive EEG recordings may facilitate single-patient treatment predictions. If successful, this approach may provide clinically useful prognostic statements in individual patients.

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-19
• Study Start: 2022-10-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical remission	4 weeks following the baseline visit	Remission, defined as MADRS \<10, and suicide risk reduction is defined as a ≥ 50% reduction in the suicidal ideation item of the MADRS scale from baseline

Secondary Outcome Measures

Name	Time	Method
Modelling	2 weeks following the baseline visit	Modelling the underlying cognitive and behavioural mechanisms to their neural causes from the effect of ketamine on TRD patients

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada