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Imaging Neural Correlates of Ketamine Using PET/MR

NCT04587778 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-03-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Austria

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04587778 on ClinicalTrials.gov