Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)

This non-randomized, single-group assignment trial (n=50) aims to investigate the glutamatergic mechanisms of psychosis and target engagement using ketamine hydrochloride in healthy volunteers.

The study, conducted by the New York State Psychiatric Institute, involves 2 identical ketamine-induced pharmacoBOLD (phBOLD) sessions at least 7 days apart. Ketamine doses will be assigned in successive 10 subject cohorts, starting at 0.08 mg/kg, with subsequent doses adjusted to determine the lowest dose that still produces a robust phBOLD response.

Participants will undergo MRI scans and clinical assessments, with the primary outcome measures being the phBOLD response to ketamine and changes in the Brief Psychiatric Rating Scale (BPRS) scores. The study aims to develop phBOLD as a biomarker for glutamatergic treatment development and explore mechanisms of psychosis. It started on January 1, 2021, and is estimated to be completed by February 1, 2025.

Topic Healthy Subjects
Compound Ketamine
Country United States of America
Visit trial
Status Active, not recruiting
Results Published No
Start date 01 January 2021
End date 01 February 2025
Phase Phase I Phase II
Design Blinded
Type Interventional
Generation First
Participants 35
Sex All
Age 18- 55
Therapy No

Trial Details

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.

NCT Number NCT04589208

Sponsors & Collaborators

New York State Psychiatric Institute
The New York State Psychiatric Institute (NYSPI), established in 1895, was one of the first institutions in the United States to integrate teaching, research and therapeutic approaches to the care of patients with mental illnesses.

Data attribution

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