Clinical trial
Deciphering Metacognition and Treatment Response in Depression With a Novel Digital Paradigm
Name
22-084
Description
To develop and test a neurocomputational model of ketamine treatment response predictions in TRD.
Trial arms
Trial start
2022-10-03
Estimated PCD
2024-10-01
Trial end
2024-12-01
Status
Recruiting
Treatment
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.
Size
30
Primary endpoint
Clinical remission
4 weeks following the baseline visit
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-11-29
1 organization
Organization
Unity Health Toronto