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Auditory MMN EEG in TRD in Response to Ketamine

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ClinicalTrials.gov Identifier: NCT05464264
Recruitment Status : Not yet recruiting
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
Sponsor:
Collaborators:
Centre for Addiction and Mental Health
Ryerson University
Information provided by (Responsible Party):
Unity Health Toronto

Tracking Information
First Submitted Date June 24, 2022
First Posted Date July 19, 2022
Last Update Posted Date July 19, 2022
Estimated Study Start Date July 2022
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2022)
Clinical remission [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 14, 2022)
Modelling [ Time Frame: 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Auditory MMN EEG in TRD in Response to Ketamine
Official Title Deciphering Metacognition and Treatment Response in Depression With a Novel Digital Paradigm
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Treatment-resistant Depression (TRD)
Intervention Drug: Ketamine
Participants suffering from TRD will receive their ketamine treatment intravenously twice weekly for three weeks (6 treatments in total). A dose of 0.5 mg/kg is infused over 40 minutes, with dose adjustments made at the psychiatrist's discretion.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 14, 2022)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Venkat Bhat, MD MSc 416-360-4000 ext 76404 Venkat.Bhat@unityhealth.to
Contact: Walter Sim, BSc 416-360-4000 ext 76404 walter.sim@unityhealth.to
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05464264
Other Study ID Numbers 22-084
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Unity Health Toronto
Original Responsible Party Same as current
Current Study Sponsor Unity Health Toronto
Original Study Sponsor Same as current
Collaborators
  • Centre for Addiction and Mental Health
  • Ryerson University
Investigators Not Provided
PRS Account Unity Health Toronto
Verification Date July 2022