Recruiting

Ketamine

Sponsor:

Unity Health Toronto

Code:

NCT05464264

Conditions

Treatment-resistant Depression (TRD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ketamine

Study Details

Brief summary:

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

Conditions

Treatment-resistant Depression (TRD)

Study ID

NCT05464264

Start date

Oct 3, 2022

Status verified date

Nov, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • Clinical remission [ Time Frame: 4 weeks following the baseline visit ]

Central Contacts and Locations

Central contacts

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1M8

Contacts

Venkat Bhat, MD MSc

4163604000

Principal Investigator:

Venkat Bhat, MD MSc

More Information

Sponsor

Unity Health Toronto

Last update posted

Nov 29, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2023-11-29.