Major Depressive DisorderPhase 1RSKetNCT04587778
Imaging Neural Correlates of Ketamine Using PET/MR
A Phase 1 study testing Ketamine Hydrochloride, Esketamine and Pilot study II: Esketamine in people with Major Depressive Disorder, run by Medical University of Vienna at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Ketamine Hydrochloride, Esketamine and Pilot study II: Esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteAustria
- Study dates
- 5 Oct 2020to 31 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Rupert Lanzenberger, Prof.
About this study
Official title: Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
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:
Read more
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
- Being tested
- Ketamine Hydrochloride, Esketamine, Placebo, Pilot study II: Esketamine, Pilot study II: Placebo
- Keywords
- Ketamine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Also called Racemic ketamine (R, S)-Ketamine
intravenous infusion
EsketamineDrug
Also called (S)-Ketamine
intravenous infusion
PlaceboDrug
Also called saline solution
intravenous infusion
Pilot study II: EsketamineDrug
Also called (S)-Ketamine
intravenous infusion
Pilot study II: PlaceboDrug
Also called Saline solution
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Pilot study II: Esketamine; Drug: Pilot study II: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cerebral metabolic rate of glucose (CMRGlu)
Change in CMRGlu between each PET/MR scan
Measured: during PETMR/during 45 minutes of infusion
Change in cerebral blood flow (CBF)
Change in CMRGlu between each PET/MR scan
Measured: during PETMR/during 45 minutes of infusion
Secondary outcomes (3)
Change in Positive and Negative Syndrome Scale
Minimum: 30, Maximum: 210; higher score indicates worse outcome
Measured: one hour after infusion to baseline
Change in Brief Psychiatric Rating Scale
Minimum: 18, Maximum: 126; higher score indicates worse outcome
Measured: one hour after infusion to baseline
Change in Clinician Administered Dissociative States Scale
Minimum: 0, Maximum: 92; higher score indicates worse outcome
Measured: one hour after infusion to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start5 Oct 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587778
- Sponsor's protocol ID
- v2_06.02.2024
- Acronym
- RSKet
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2020
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Neural Correlates of Antidepressant Action of Ketamine Stereoisomers Using Pharmacological PET/MR Imaging and Metabolite Analysis.
- ClinicalTrials.gov ID
- NCT04587778
- Acronym / sponsor ID
- RSKet / v2_06.02.2024
- Conditions
- Major Depressive Disorder
- Keywords
- Ketamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esketamine ((S)-Ketamine) | Experimental | Drug: Ketamine Hydrochloride, Drug: Esketamine, Drug: PlaceboSingle-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. |
| Racemic ketamine ((R,S)-Ketamine) | Experimental | Drug: Ketamine Hydrochloride, Drug: Esketamine, Drug: PlaceboSingle-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. |
| Pilot study II: Esketamine ((S)-Ketamine) | Experimental | Drug: Pilot study II: Esketamine, Drug: Pilot study II: PlaceboIn a cross-over study design, esketamine will be administered during the first scan and placebo during the second scan. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochlorideAlso: Racemic ketamine (R, S)-Ketamineintravenous infusion | Drug | Esketamine ((S)-Ketamine), Racemic ketamine ((R,S)-Ketamine) |
| EsketamineAlso: (S)-Ketamineintravenous infusion | Drug | Esketamine ((S)-Ketamine), Racemic ketamine ((R,S)-Ketamine) |
| PlaceboAlso: saline solutionintravenous infusion | Drug | Esketamine ((S)-Ketamine), Racemic ketamine ((R,S)-Ketamine) |
| Pilot study II: EsketamineAlso: (S)-Ketamineintravenous infusion | Drug | Pilot study II: Esketamine ((S)-Ketamine) |
| Pilot study II: PlaceboAlso: Saline solutionintravenous infusion | Drug | Pilot study II: Esketamine ((S)-Ketamine) |
Primary outcome
Change in Cerebral metabolic rate of glucose (CMRGlu)
Time frame: during PETMR/during 45 minutes of infusion
Change in CMRGlu between each PET/MR scan
Change in cerebral blood flow (CBF)
Time frame: during PETMR/during 45 minutes of infusion
Change in CMRGlu between each PET/MR scan
3 secondary outcomes
Change in Positive and Negative Syndrome Scale
Time frame: one hour after infusion to baseline
Change in Brief Psychiatric Rating Scale
Time frame: one hour after infusion to baseline
Change in Clinician Administered Dissociative States Scale
Time frame: one hour after infusion to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine Hydrochloride, Esketamine and Pilot study II: Esketamine in people with Major Depressive Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rupert Lanzenberger, Prof. (004314040035760, rupert.lanzenberger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cerebral metabolic rate of glucose (CMRGlu) (time frame: during PETMR/during 45 minutes of infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.