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Imaging Neural Correlates of Ketamine Using PET/MR (RSKet)

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Esketamine
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring Ketamine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Esketamine ((S)-Ketamine)

    Racemic ketamine ((R,S)-Ketamine)

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in Cerebral metabolic rate of glucose (CMRGlu)
    Change in CMRGlu between each PET/MR scan
    Change in cerebral blood flow (CBF)
    Change in CMRGlu between each PET/MR scan

    Secondary Outcome Measures

    Change in Positive and Negative Syndrome Scale
    Minimum: 30, Maximum: 210; higher score indicates worse outcome
    Change in Brief Psychiatric Rating Scale
    Minimum: 18, Maximum: 126; higher score indicates worse outcome
    Change in Clinician Administered Dissociative States Scale
    Minimum: 0, Maximum: 92; higher score indicates worse outcome

    Full Information

    First Posted
    September 28, 2020
    Last Updated
    October 8, 2020
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04587778
    Brief Title
    Imaging Neural Correlates of Ketamine Using PET/MR
    Acronym
    RSKet
    Official Title
    Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Ketamine

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    65 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Esketamine ((S)-Ketamine)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Racemic ketamine ((R,S)-Ketamine)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine Hydrochloride
    Other Intervention Name(s)
    Racemic ketamine (R, S)-Ketamine
    Intervention Description
    intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine
    Other Intervention Name(s)
    (S)-Ketamine
    Intervention Description
    intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    saline solution
    Intervention Description
    intravenous infusion
    Primary Outcome Measure Information:
    Title
    Change in Cerebral metabolic rate of glucose (CMRGlu)
    Description
    Change in CMRGlu between each PET/MR scan
    Time Frame
    during PETMR/during 45 minutes of infusion
    Title
    Change in cerebral blood flow (CBF)
    Description
    Change in CMRGlu between each PET/MR scan
    Time Frame
    during PETMR/during 45 minutes of infusion
    Secondary Outcome Measure Information:
    Title
    Change in Positive and Negative Syndrome Scale
    Description
    Minimum: 30, Maximum: 210; higher score indicates worse outcome
    Time Frame
    one hour after infusion to baseline
    Title
    Change in Brief Psychiatric Rating Scale
    Description
    Minimum: 18, Maximum: 126; higher score indicates worse outcome
    Time Frame
    one hour after infusion to baseline
    Title
    Change in Clinician Administered Dissociative States Scale
    Description
    Minimum: 0, Maximum: 92; higher score indicates worse outcome
    Time Frame
    one hour after infusion to baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Imaging Neural Correlates of Ketamine Using PET/MR

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