Imaging Neural Correlates of Ketamine Using PET/MR

Major Depressive Disorder Clinical Trial

— RSKet  

Official title:

Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04587778
• Other study ID #: v2_06.02.2024
• Status: Recruiting
• Phase: Phase 1
• Start date: October 5, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Medical University of Vienna
• Contact: Rupert Lanzenberger, Prof.
• Phone: 004314040035760
• Email: rupert.lanzenberger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Ketamine Hydrochloride
intravenous infusion
• Esketamine
intravenous infusion
• Placebo
intravenous infusion
• Pilot study II: Esketamine
intravenous infusion
• Pilot study II: Placebo
intravenous infusion

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cerebral metabolic rate of glucose (CMRGlu)	Change in CMRGlu between each PET/MR scan	during PETMR/during 45 minutes of infusion
Primary	Change in cerebral blood flow (CBF)	Change in CMRGlu between each PET/MR scan	during PETMR/during 45 minutes of infusion
Secondary	Change in Positive and Negative Syndrome Scale	Minimum: 30, Maximum: 210; higher score indicates worse outcome	one hour after infusion to baseline
Secondary	Change in Brief Psychiatric Rating Scale	Minimum: 18, Maximum: 126; higher score indicates worse outcome	one hour after infusion to baseline
Secondary	Change in Clinician Administered Dissociative States Scale	Minimum: 0, Maximum: 92; higher score indicates worse outcome	one hour after infusion to baseline