Auditory MMN EEG in TRD in Response to Ketamine

NCT ID: NCT05464264

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2024-12-31

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.

Conditions

Treatment-resistant Depression (TRD)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Ketamine

Participants suffering from TRD will receive their ketamine treatment intravenously twice weekly for two weeks (4 treatments in total). A dose of 0.5 mg/kg is infused over 40 minutes, with dose adjustments made at the psychiatrist's discretion.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

Toronto Metropolitan University

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Venkat Bhat, MD MSc

Role: CONTACT

Venkat.Bhat@unityhealth.to

416-360-4000 ext. 76404

Facility Contacts

Venkat Bhat, MD MSc

Role: primary

4163604000 ext. 76404

References

Martin J, Gholamali Nezhad F, Rueda A, Lee GH, Charlton CE, Soltanzadeh M, Ladha KS, Krishnan S, Diaconescu AO, Bhat V. Predicting treatment response to ketamine in treatment-resistant depression using auditory mismatch negativity: Study protocol. PLoS One. 2024 Aug 8;19(8):e0308413. doi: 10.1371/journal.pone.0308413. eCollection 2024.

Reference Type: DERIVED

PMID: 39116153 (View on PubMed)

Other Identifiers

22-084

Identifier Type: -

Identifier Source: org_study_id