Ketamine molecule:

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Ketamine Clinical Trials

Glutamatergic Mechanisms of Psychosis and Target Engagement: Aim2

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Id: NCT05401227

Organisation Name: New York State Psychiatric Institute

Overal Status: Not yet recruiting

Start Date: December 15, 2022

Last Update: October 28, 2022

Lead Sponsor: New York State Psychiatric Institute

Brief Summary: This is a randomized, double-blind, and placebo controlled. 120 HV will be randomized to one of three ketamine arms, delivered in a bolus dose over one minute: low (0.086 mg/kg), medium (0.125 mg/kg), and high (0.23 mg/kg).

Within each ketamine arm, subjects will be randomized to 4 days of TS-134 20 mg or placebo in a 5:3 ratio (25 TS-134:15 placebo). Following an outpatient Screening Period (up to 31 days), eligible subjects will undergo a 5-day inpatient Treatment Period. During the study, each subject will undergo a total of two ketamine sessions: a first session during the Screening Period and a second session on Day 4 of the Treatment Period, conducted at least 7 days apart. All randomized subjects will be dosed with TS-134 or placebo daily in a fed state for 4 days during the study, titrated to 20 mg over the first 2 days.

  • Healthy

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