Imaging Neural Correlates of Ketamine Using PET/MR

Ketamine

Brief 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)

Intervention / Treatment

  • Ketamine Hydrochloride (DRUG)
    intravenous infusion
  • Esketamine (DRUG)
    intravenous infusion
  • Placebo (DRUG)
    intravenous infusion

Condition or Disease

  • Major Depressive Disorder

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Not yet recruiting
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 65 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Oct 01, 2020 ESTIMATED
    Primary Completion: Sep 30, 2023 ESTIMATED
    Completion Date: Sep 30, 2023 ESTIMATED
    Study First Posted: Oct 14, 2020 ACTUAL
    Last Updated: Oct 08, 2020

    Sponsors / Collaborators

    Lead Sponsor: Medical University of Vienna
    Responsible Party: N/A

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • Change in CMRGlu between each PET/MR scan

    • Change in CMRGlu between each PET/MR scan

    Secondary Outcomes

    • Minimum: 30, Maximum: 210; higher score indicates worse outcome

    • Minimum: 18, Maximum: 126; higher score indicates worse outcome

    • Minimum: 0, Maximum: 92; higher score indicates worse outcome

    More Details

    NCT Number: NCT04587778
    Acronym: RSKet
    Other IDs: v1.7_21.02.2020
    Study URL: https://clinicaltrials.gov/study/NCT04587778
    Last updated: Sep 29, 2023