Imaging Neural Correlates of Ketamine Using PET/MR

NCT04587778 | Recruiting Phase 1 DMC

• 1 other identifier: v2_06.02.2024
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Ketamine

Outcome Measures

Primary Outcomes (2)

• Change in Cerebral metabolic rate of glucose (CMRGlu)

  Change in CMRGlu between each PET/MR scan

  during PETMR/during 45 minutes of infusion

• Change in cerebral blood flow (CBF)

  Change in CMRGlu between each PET/MR scan

  during PETMR/during 45 minutes of infusion

Secondary Outcomes (3)

• Change in Positive and Negative Syndrome Scale

  one hour after infusion to baseline

• Change in Brief Psychiatric Rating Scale

  one hour after infusion to baseline

• Change in Clinician Administered Dissociative States Scale

  one hour after infusion to baseline

Study Arms (3)

Esketamine ((S)-Ketamine)

EXPERIMENTAL

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; Drug: Esketamine; Drug: Placebo

Racemic ketamine ((R,S)-Ketamine)

EXPERIMENTAL

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; Drug: Esketamine; Drug: Placebo

Pilot study II: Esketamine ((S)-Ketamine)

EXPERIMENTAL

In a cross-over study design, esketamine will be administered during the first scan and placebo during the second scan.

Drug: Pilot study II: Esketamine; Drug: Pilot study II: Placebo

Interventions

Ketamine Hydrochloride DRUG

intravenous infusion

Also known as: Racemic ketamine (R, S)-Ketamine

Esketamine ((S)-Ketamine); Racemic ketamine ((R,S)-Ketamine)

Esketamine DRUG

intravenous infusion

Also known as: (S)-Ketamine

Esketamine ((S)-Ketamine); Racemic ketamine ((R,S)-Ketamine)

Placebo DRUG

intravenous infusion

Also known as: saline solution

Esketamine ((S)-Ketamine); Racemic ketamine ((R,S)-Ketamine)

Pilot study II: Esketamine DRUG

intravenous infusion

Also known as: (S)-Ketamine

Pilot study II: Esketamine ((S)-Ketamine)

Pilot study II: Placebo DRUG

intravenous infusion

Also known as: Saline solution

Pilot study II: Esketamine ((S)-Ketamine)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Failure to comply with the study protocol or to follow the instruction of the investigating team.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine; Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Rupert Lanzenberger, Prof.

CONTACT

004314040035760; rupert.lanzenberger@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 14, 2020
• Study Start: October 5, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)