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History of Changes for Study: NCT04587778
Imaging Neural Correlates of Ketamine Using PET/MR (RSKet)
Latest version (submitted October 8, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 8, 2020 None (earliest Version on record)
Comparison Format:

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Study NCT04587778
Submitted Date:  October 8, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: v1.7_21.02.2020
Brief Title: Imaging Neural Correlates of Ketamine Using PET/MR (RSKet)
Official Title: Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Not yet recruiting
Study Start: October 2020
Primary Completion: September 30, 2023 [Anticipated]
Study Completion: September 30, 2023 [Anticipated]
First Submitted: September 28, 2020
First Submitted that
Met QC Criteria:
October 8, 2020
First Posted: October 14, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 8, 2020
Last Update Posted: October 14, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Medical University of Vienna
Responsible Party: Principal Investigator
Investigator: Rupert Lanzenberger
Official Title: Prof.
Affiliation: Medical University of Vienna
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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)
Detailed Description:
Open or close this module Conditions
Conditions: Major Depressive Disorder
Keywords: Ketamine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 65 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • Racemic ketamine (R, S)-Ketamine
Drug: Esketamine
intravenous infusion
Other Names:
  • (S)-Ketamine
Drug: Placebo
intravenous infusion
Other Names:
  • 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 Names:
  • Racemic ketamine (R, S)-Ketamine
Drug: Esketamine
intravenous infusion
Other Names:
  • (S)-Ketamine
Drug: Placebo
intravenous infusion
Other Names:
  • saline solution
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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