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

Plain Language Summary

Simplified for easier understanding

This study uses combined PET and MRI brain scanning to understand how a drug called ketamine affects the brain — specifically, it looks at opioid receptors and other brain systems that ketamine interacts with. This is a healthy volunteer study to understand the brain mechanisms behind ketamine's effects, which may inform its use as a treatment for depression. **You may be eligible if...** - You are 18–55 years old - You are right-handed - You are in good physical and mental health with no history of psychiatric or neurological conditions - You do not have a history of substance abuse - You are willing and able to give informed consent **You may NOT be eligible if...** - You have any current or past psychiatric or neurological illness - You have a first-degree relative (parent, sibling, or child) with a psychotic disorder - You are pregnant or currently breastfeeding - You have any metal implants that are incompatible with MRI - You have had significant radiation exposure from prior research studies - You weigh more than 100 kg (due to radiation dose limits) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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