Imaging Neural Correlates of Ketamine Using PET/MR

Overview

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)

Full Title of Study: “Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 30, 2023

Interventions

  • Drug: Ketamine Hydrochloride
    • intravenous infusion
  • Drug: Esketamine
    • intravenous infusion
  • Drug: Placebo
    • intravenous infusion

Arms, Groups and Cohorts

  • Experimental: Esketamine ((S)-Ketamine)
    • Single-blind placebo (saline) infusion will be performed during the first PET/MR scan in all subjects, i.e. both arms. In a cross-over study design, esketamine will be administered during the second scan and racemic ketamine during the third scan.
  • Experimental: Racemic ketamine ((R,S)-Ketamine)
    • Single-blind placebo (saline) infusion will be performed during the first PET/MR scan in all subjects, i.e. both arms. In a cross-over study design, racemic ketamine will be administered during the second scan and esketamine during the third scan.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Cerebral metabolic rate of glucose (CMRGlu)
    • Time Frame: during PETMR/during 45 minutes of infusion
    • Change in CMRGlu between each PET/MR scan
  • Change in cerebral blood flow (CBF)
    • Time Frame: during PETMR/during 45 minutes of infusion
    • Change in CMRGlu between each PET/MR scan

Secondary Measures

  • Change in Positive and Negative Syndrome Scale
    • Time Frame: one hour after infusion to baseline
    • Minimum: 30, Maximum: 210; higher score indicates worse outcome
  • Change in Brief Psychiatric Rating Scale
    • Time Frame: one hour after infusion to baseline
    • Minimum: 18, Maximum: 126; higher score indicates worse outcome
  • Change in Clinician Administered Dissociative States Scale
    • Time Frame: one hour after infusion to baseline
    • Minimum: 0, Maximum: 92; higher score indicates worse outcome

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rupert Lanzenberger, Prof. – Medical University of Vienna

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