Major Depressive Disorder
Conditions
Keywords
Ketamine
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.
Interventions
DRUGKetamine Hydrochloride
intravenous infusion
DRUGEsketamine
intravenous infusion
DRUGPlacebo
intravenous infusion
DRUGPilot study II: Esketamine
intravenous infusion
DRUGPilot study II: Placebo
intravenous infusion
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cerebral metabolic rate of glucose (CMRGlu) | during PETMR/during 45 minutes of infusion | Change in CMRGlu between each PET/MR scan |
| Change in cerebral blood flow (CBF) | during PETMR/during 45 minutes of infusion | Change in CMRGlu between each PET/MR scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive and Negative Syndrome Scale | one hour after infusion to baseline | Minimum: 30, Maximum: 210; higher score indicates worse outcome |
| Change in Brief Psychiatric Rating Scale | one hour after infusion to baseline | Minimum: 18, Maximum: 126; higher score indicates worse outcome |
| Change in Clinician Administered Dissociative States Scale | one hour after infusion to baseline | Minimum: 0, Maximum: 92; higher score indicates worse outcome |
Countries
Austria
Contacts
Primary ContactRupert Lanzenberger, Prof.
Outcome results
None listed