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

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ClinicalTrials.gov Identifier: NCT04587778
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date October 14, 2020
Estimated Study Start Date  ICMJE October 2020
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging Neural Correlates of Ketamine Using PET/MR
Official Title  ICMJE Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine Hydrochloride
    intravenous infusion
    Other Name: Racemic ketamine (R, S)-Ketamine
  • Drug: Esketamine
    intravenous infusion
    Other Name: (S)-Ketamine
  • Drug: Placebo
    intravenous infusion
    Other Name: saline solution
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Ketamine Hydrochloride
    • Drug: Esketamine
    • Drug: Placebo
  • 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.

    Interventions:
    • Drug: Ketamine Hydrochloride
    • Drug: Esketamine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2020)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04587778
Other Study ID Numbers  ICMJE v1.7_21.02.2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Rupert Lanzenberger, Medical University of Vienna
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of Vienna
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP