RecruitingPhase 1NCT04587778

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.

Sponsor

Medical University of Vienna

Enrollment

65 participants

Start Date

Oct 5, 2020

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

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 Criteria8

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.