Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04589208
PHASE1/PHASE2

Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)

Sponsor: New York State Psychiatric Institute

View on ClinicalTrials.gov

Summary

50 healthy volunteers (HV) will participate in 2 identical ketamine-induced pharmacoBOLD (phBOLD) sessions at least 7 days apart. On both days, clinical assessments will be performed following removal of the subject from the scanner. HV will be discharged home after clearance by the study physician. This study will assign ketamine doses in successive 10 subject cohorts. The ketamine dose for the 1st cohort will start at 0.08 mg/kg. For subsequent cohorts, the bolus will be successively reduced or increased by 0.02 mg/kg (n=10/dose) to determine the lowest dose of ketamine that still produces a robust phBOLD response. The study will be subject and rater blind, i.e. subjects and raters, will be blinded to the treatment (ketamine dose) group. The study physician will be aware of the ketamine dose, and ketamine dose will be the same for both sessions. Subjects will not be told what the exact ketamine dose they will receive, but it will be based on their weight and will be no higher than 0.08 mg/kg.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2021-01-01

Completion Date

2027-04-01

Last Updated

2026-07-13

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Ketamine Hydrochloride

We will assign ketamine doses in successive 10 subject cohorts. The ketamine dose for the 1st cohort will start at 0.08 mg/kg. For subsequent cohorts, the bolus will be successively reduced or increased by 0.02 mg/kg (n=10/dose) to determine the lowest dose of ketamine that still produces a robust phBOLD response

Locations (1)

New York State Psychiatric

New York, New York, United States