Clinical trial NCT04587778: Imaging Neural Correlates of Ketamine Using PET/MR
Official title: Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: Ketamine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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)

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.


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.

Primary outcomes:
measure: Change in Cerebral metabolic rate of glucose (CMRGlu)
timeFrame: during PETMR/during 45 minutes of infusion
measure: Change in cerebral blood flow (CBF)
timeFrame: during PETMR/during 45 minutes of infusion
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scale
timeFrame: one hour after infusion to baseline
measure: Change in Brief Psychiatric Rating Scale
timeFrame: one hour after infusion to baseline
measure: Change in Clinician Administered Dissociative States Scale
timeFrame: one hour after infusion to baseline
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: