Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05401227 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Glutamatergic Mechanisms: Aim2

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Interventions: Ketamine (Drug), Placebo (Drug), Ts-134 (Drug) to Ketamine (Drug), Placebo (Drug), Ts-134 or XT (Drug)v14
  2. Trial status: Suspended to Recruiting
    • Site details revised
    v13
  3. Study description shortened, about 166 words
    • Eligibility criteria expanded, about 5 words
    v12
  4. Re-verified, no change to tracked fieldsv11
  5. Primary completion date: Aug 15, 2025 to Aug 2028
    • Study completion date: Aug 15, 2027 to Aug 2029
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study completion date: Aug 15, 2026 to Aug 15, 2027v9
  2. Sponsor's reason: In June 2023, NYSPI decided to undertake an Institute-wide safety review of human subjects research. The primary objective of the pause is… to U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects…v8
  3. Trial status: Recruiting to Suspended Sponsor's reason: In June 2023, NYSPI decided to undertake an Institute-wide safety review of human subjects research. The primary objective of the pause is…
    • Site details revised
    v7
  4. Start date: Oct 1, 2022 to Oct 15, 2022v6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 15, 2022 to Oct 1, 2022
    • Study description shortened, about 17 words
    v5
  6. Study description shortened, about 24 wordsv4
  7. Study description expanded, about 48 wordsv3
  8. Start date: Aug 15, 2022 to Dec 15, 2022v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In the present study, 120 healthy volunteers (HV) will be randomized to one of three ketamine-induced pharmacoBOLD (phBOLD) arms: low, medium, and high. Within each ketamine arm, participants will be randomized to 4 days of "study drug" \[TS-134 (1st 20 participants) or XT (remaining 100 participants)\] or placebo in a 5:3 ratio (25 study drug:15 placebo per arm). During the study, each participant will undergo a Screening Period (up to 31 days), a 4-day Treatment Period, and a total of two phBOLD sessions: a first session at Baseline and a second session on Day 4 of the Treatment Period, conducted at least 7 days apart, and a follow up visit.
Trial Details
NCT Number NCT05401227
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Healthy
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov