Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
65 participants
INTERVENTIONAL
2020-10-05
2025-03-31
Brief Summary
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Pilot study I:
A pilot study with healthy controls will be performed in order to investigate pharmacokinetic behavior and acute behavioral effects of intravenous ketamine infusion.
Pilot study II:
A pilot study including 15 healthy volunteers will be performed in order to optimize scanning procedures. The pilot study follows a randomized, placebo-controlled, double-blind, cross-over study design. After enrollment into the study all subjects will undergo two \[18F\]FDG PET/CT scans in the course of which they will receive either S-ketamine or placebo during the first scan and the respective other study medication during the second scan.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
Ketamine Hydrochloride
intravenous infusion
Esketamine
intravenous infusion
Placebo
intravenous infusion
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.
Ketamine Hydrochloride
intravenous infusion
Esketamine
intravenous infusion
Placebo
intravenous infusion
Pilot study II: Esketamine ((S)-Ketamine)
In a cross-over study design, esketamine will be administered during the first scan and placebo during the second scan.
Pilot study II: Esketamine
intravenous infusion
Pilot study II: Placebo
intravenous infusion
Interventions
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Ketamine Hydrochloride
intravenous infusion
Esketamine
intravenous infusion
Placebo
intravenous infusion
Pilot study II: Esketamine
intravenous infusion
Pilot study II: Placebo
intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Rupert Lanzenberger
Prof.
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Rupert Lanzenberger, Prof.
Role: primary
Other Identifiers
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v2_06.02.2024
Identifier Type: -
Identifier Source: org_study_id
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