Glutamatergic Mechanisms: Aim2

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT05401227
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ketamine — DRUG
    Ketamine during an MRI
  • Ts-134 — DRUG
    4 days of TS-134 20 mg
  • Placebo — DRUG
    4 days of placebo TS-134

Study Details

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.

Key Dates

First listed
Jun 2, 2022
Start date
Oct 15, 2022
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High Ketamine, TS-134 (first 20 subjects) or XT (remaining 100 subjects)
    Two administrations of ketamine 0.23 mg/kg pre post 4 days of TS-134 or XT
  • Placebo Comparator: High ketamine, placebo
    Two administrations of ketamine 0.23 mg/kg pre post 4 days of placebo
  • Experimental: Medium Ketamine, TS-134 (first 20 subjects) or XT (remaining 100 subjects)
    Two administrations of ketamine 0.125 mg/kg pre post 4 days of TS-134 or XT
  • Placebo Comparator: Medium Ketamine, placebo
    Two administrations of ketamine 0.125 mg/kg pre post 4 days of placebo
  • Experimental: Low Ketamine, TS-134 (first 20 subjects) or XT (remaining 100 subjects)
    Two administrations of ketamine 0.086 mg/kg pre post 4 days of TS-134 or XT
  • Placebo Comparator: Low Ketamine, placebo
    Two administrations of ketamine 0.06 mg/kg pre post 4 days of placebo

Primary Outcome Measure

Final PharmacoBOLD signals in pre-specified ROIs [ Time Frame: Baseline and Day 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYSPINew YorkNew York10032
Joshua Kantrowitz, MD

Find similar trials in New York, NY

By research site
NYSPI· New York, NY

Related Studies