Auditory MMN EEG in TRD in Response to Ketamine

NCT05464264 | Unknown

• 1 other identifier: 22-084
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Treatment-resistant Depression (TRD)

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  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

  4 weeks following the baseline visit

Secondary Outcomes (1)

• Modelling

  2 weeks following the baseline visit

Interventions

Ketamine DRUG

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient participants diagnosed as suffering from a Treatment-Resistant Depression (TRD) that meet the criteria from Diagnosis and Statistical Manual for Mental Disorders (DSM-5), will be eligible to participate in this data collection study. Participants who have agreed to receive ketamine treatments as part of the Interventional Psychiatry Clinical Program at St. Michael's Hospital will be approached and recruited.

You may qualify if:

• 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).
• \. Competent to consent-based on their ability to provide a spontaneous narrative description of the key elements of the study.
• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Centre for Addiction and Mental Health: collaborator
• Toronto Metropolitan University: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1M8, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 39116153 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Venkat Bhat, MD MSc

CONTACT

416-360-4000; Venkat.Bhat@unityhealth.to

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 19, 2022
• Study Start: October 3, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)