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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

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)

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Ketamine Hydrochloride Drug: Esketamine Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.

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




Primary Outcome Measures :
  1. 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

  2. Change in cerebral blood flow (CBF) [ Time Frame: during PETMR/during 45 minutes of infusion ]
    Change in CMRGlu between each PET/MR scan


Secondary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale [ Time Frame: one hour after infusion to baseline ]
    Minimum: 30, Maximum: 210; higher score indicates worse outcome

  2. Change in Brief Psychiatric Rating Scale [ Time Frame: one hour after infusion to baseline ]
    Minimum: 18, Maximum: 126; higher score indicates worse outcome

  3. Change in Clinician Administered Dissociative States Scale [ Time Frame: one hour after infusion to baseline ]
    Minimum: 0, Maximum: 92; higher score indicates worse outcome



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Rupert Lanzenberger, Prof., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04587778    
Other Study ID Numbers: v1.7_21.02.2020
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rupert Lanzenberger, Medical University of Vienna:
Ketamine
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Ketamine
Esketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Psychotropic Drugs