Clinical Trial

Glutamatergic Mechanisms: Aim2

Recruiting Phase 1
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Summary
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2022-06-01; most recent amendment 2026-07-10.
Status change: Suspended → Recruiting 2026-07-10
Status change: Recruiting → Suspended 2023-08-07
Status change: Not Yet Recruiting → Recruiting 2023-01-03
Trial Details
NCT Number NCT05401227
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute of Mental Health (NIMH)
Conditions Healthy
Enrollment 120 participants
Start Date 2022-10-15
Primary Completion 2028-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-13