NCT04587778

Imaging Neural Correlates of Ketamine Using PET/MR

Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this randomized, placebo-controlled study is to investigate pharmacodynamic differences between racemic ketamine and esketamine using functional fluorodeoxyglucose (\[18F\]FDG) positron emission tomography/magnetic resonance imaging (PET/MR) Pilot study I: A pilot study with healthy controls will be performed in order to investigate pharmacokinetic behavior and acute behavioral effects of intravenous ketamine infusion. Pilot study II: A pilot study including 15 healthy volunteers will be performed in order to optimize scanning procedures. The pilot study follows a randomized, placebo-controlled, double-blind, cross-over study design. After enrollment into the study all subjects will undergo two \[18F\]FDG PET/CT scans in the course of which they will receive either S-ketamine or placebo during the first scan and the respective other study medication during the second scan.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	intravenous infusion
DRUG	Esketamine	intravenous infusion
DRUG	Placebo	intravenous infusion
DRUG	Pilot study II: Esketamine	intravenous infusion
DRUG	Pilot study II: Placebo	intravenous infusion

Timeline

• Start date: 2020-10-05
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2020-10-14
• Last updated: 2024-03-04

Locations

1 site across 1 country: Austria