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Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Trial status: Suspended to Active, Not Recruitingv13
  2. Primary completion date: Dec 1, 2025 to Jan 1, 2027
    • Study completion date: Feb 1, 2026 to Apr 1, 2027
    v12
  3. Re-verified, no change to tracked fieldsv11
  4. Trial status: Active, Not Recruiting to Suspended Sponsor's reason: NIMH institute wide suspension
    • Primary completion date: Dec 1, 2024 to Dec 1, 2025
    • Study completion date: Feb 1, 2025 to Feb 1, 2026
    v10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Dec 1, 2022 to Dec 1, 2024
    • Study completion date: Feb 1, 2024 to Feb 1, 2025
    v8
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 35
    • Study completion date: Feb 1, 2023 to Feb 1, 2024
    • Site details revised
    v7
  3. 3 versions Re-verified since Jan 21, 2021, no change to tracked fieldsv4-v6
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Dec 1, 2021 to Dec 1, 2022
    • Start date: Dec 1, 2020 to Jan 1, 2021
    • Study sites: 0 to 1
    • Study completion date: Feb 1, 2022 to Feb 1, 2023
  5. Collaborator revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
50 healthy volunteers (HV) will participate in 2 identical ketamine-induced pharmacoBOLD (phBOLD) sessions at least 7 days apart. On both days, clinical assessments will be performed following removal of the subject from the scanner. HV will be discharged home after clearance by the study physician. This study will assign ketamine doses in successive 10 subject cohorts. The ketamine dose for the 1st cohort will start at 0.08 mg/kg. For subsequent cohorts, the bolus will be successively reduced or increased by 0.02 mg/kg (n=10/dose) to determine the lowest dose of ketamine that still produces a robust phBOLD response. The study will be subject and rater blind, i.e. subjects and raters, will be blinded to the treatment (ketamine dose) group. The study physician will be aware of the ketamine dose, and ketamine dose will be the same for both sessions. Subjects will not be told what the exact ketamine dose they will receive, but it will be based on their weight and will be no higher than 0.08 mg/kg.
Trial Details
NCT Number NCT04589208
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Healthy
Related terms Schizophrenia
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov