drugset / Trial / NCT05401227
Glutamatergic Mechanisms: Aim2
Phase 1
Recruiting
120 enrolled
New York State Psychiatric Institute
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2022-10-15
- Primary completion
- 2028-08
- Completion
- 2029-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 0.06 mg/kg | — |
| Subject | Ketamine | Small molecule | 0.086 mg/kg | — |
| Subject | Ketamine | Small molecule | 0.125 mg/kg | — |
| Subject | Ketamine | Small molecule | 0.23 mg/kg | — |
| Subject | TS-134 | Unknown | 20 mg | — |
Indications
No indication recorded.