Imaging Neural Correlates of Ketamine Using PET/MR (RSKet)
Primary Purpose
Major Depressive Disorder
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Esketamine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Major Depressive Disorder focused on measuring Ketamine
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Esketamine ((S)-Ketamine)
Racemic ketamine ((R,S)-Ketamine)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Cerebral metabolic rate of glucose (CMRGlu)
Change in CMRGlu between each PET/MR scan
Change in cerebral blood flow (CBF)
Change in CMRGlu between each PET/MR scan
Secondary Outcome Measures
Change in Positive and Negative Syndrome Scale
Minimum: 30, Maximum: 210; higher score indicates worse outcome
Change in Brief Psychiatric Rating Scale
Minimum: 18, Maximum: 126; higher score indicates worse outcome
Change in Clinician Administered Dissociative States Scale
Minimum: 0, Maximum: 92; higher score indicates worse outcome
Full Information
NCT ID
NCT04587778
First Posted
September 28, 2020
Last Updated
October 8, 2020
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04587778
Brief Title
Imaging Neural Correlates of Ketamine Using PET/MR
Acronym
RSKet
Official Title
Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Ketamine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Esketamine ((S)-Ketamine)
Arm Type
Experimental
Arm Description
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.
Arm Title
Racemic ketamine ((R,S)-Ketamine)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Other Intervention Name(s)
Racemic ketamine (R, S)-Ketamine
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Esketamine
Other Intervention Name(s)
(S)-Ketamine
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline solution
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Change in Cerebral metabolic rate of glucose (CMRGlu)
Description
Change in CMRGlu between each PET/MR scan
Time Frame
during PETMR/during 45 minutes of infusion
Title
Change in cerebral blood flow (CBF)
Description
Change in CMRGlu between each PET/MR scan
Time Frame
during PETMR/during 45 minutes of infusion
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale
Description
Minimum: 30, Maximum: 210; higher score indicates worse outcome
Time Frame
one hour after infusion to baseline
Title
Change in Brief Psychiatric Rating Scale
Description
Minimum: 18, Maximum: 126; higher score indicates worse outcome
Time Frame
one hour after infusion to baseline
Title
Change in Clinician Administered Dissociative States Scale
Description
Minimum: 0, Maximum: 92; higher score indicates worse outcome
Time Frame
one hour after infusion to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Imaging Neural Correlates of Ketamine Using PET/MR
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