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Unknown statusPhase 1

Imaging Neural Correlates of Ketamine Using PET/MR

NCT04587778 · RSKet · Medical University of Vienna

Closed to entry
Status
Not accepting participants
Phase 1
Phase
65
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Cerebral metabolic rate of glucose (CMRGlu)

    Measured over during PETMR/during 45 minutes of infusion

  • Change in cerebral blood flow (CBF)

    Measured over during PETMR/during 45 minutes of infusion

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 55 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * General health based on medical history, physical examination and structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID) * Age 18 to 55 years * Right-handedness (due to potential lateralization effects of lefthanded subjects) * Willingness and competence to sign the informed consent form. Exclusion Criteria: * Current or history of psychiatric or neurological disease * Current medical illness requiring treatment * Pregnancy or current breastfeeding * Current or former substance abuse * Diagnosis of an Axis-1 psychotic disorder in a first-degree relative * Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts * For subjects participating in earlier studies using ionizing radiation, the total radiation exposure of 30 millisievert (mSv) over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection (www.ris.bka.gv.at). Accordingly, body weight \>100kg is an exclusion criterion (5.1 Megabequerel (MBq)/kg \* 100kg \* 0.019 mSv/MBq\* 0.885 = 8.58 mSv per scan, the factor 0.885 is considered due to continuous radioligand infusion, see PET scanning). * Failure to comply with the study protocol or to follow the instruction of the investigating team.

Where

1 study site

FacilityCityRegionCountry
Medical University of ViennaVienna—Austria

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04587778 on ClinicalTrials.gov →

Last updated in the registry 2024-03-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 7 trials from Medical University of Vienna →