Imaging Neural Correlates of Ketamine Using PET/MR

Phase 1RecruitingNCT04587778

Medical University of Vienna65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Cerebral metabolic rate of glucose (CMRGlu)

Change in CMRGlu between each PET/MR scan

Time frame: during PETMR/during 45 minutes of infusion

Change in cerebral blood flow (CBF)

Change in CMRGlu between each PET/MR scan

Time frame: during PETMR/during 45 minutes of infusion

Secondary Outcomes

Change in Positive and Negative Syndrome Scale

Minimum: 30, Maximum: 210; higher score indicates worse outcome

Time frame: one hour after infusion to baseline

Change in Brief Psychiatric Rating Scale

Minimum: 18, Maximum: 126; higher score indicates worse outcome

Time frame: one hour after infusion to baseline

Change in Clinician Administered Dissociative States Scale

Minimum: 0, Maximum: 92; higher score indicates worse outcome

Time frame: one hour after infusion to baseline

Imaging Neural Correlates of Ketamine Using PET/MR

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts