Major Depressive DisorderPhase 1NCT05320107
The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects
A Phase 1 study testing Ketamine in people with Major Depressive Disorder, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to assess the impact of ketamine on aesthetic perception and processing. This study assesses the role of these effects in facilitating ketamine's antidepressant properties, with a focus on anhedonia. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2022to 28 Feb 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 and physical examination
- Psychiatric health based on structured clinical interview for DSM-5 (SCID) for healthy controls
- Major depressive episode (first or recurrent) based on structured clinical interview for DSM-5 and ICD-10 for patients
- 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 neurological disease
- Current medical illness requiring treatment
- Psychiatric diagnosis for healthy individuals
- Psychiatric comorbidity with the exception of anxiety disorders for depressed individuals
- Pregnancy or current breastfeeding
- Current or former substance abuse
Show all 9Show fewer
- Previous ketamine use in lifetime
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Rupert Lanzenberger, MD
About this study
Official title: Unraveling the Aesthetic Mind in Anhedonia, Insights From Pharmacological Imaging of the Human Brain: A Single-blind, Randomized, Placebo-controlled Cross-over Study
The aim of this study is to assess the impact of ketamine on aesthetic perception and processing. This study assesses the role of these effects in facilitating ketamine's antidepressant properties, with a focus on anhedonia. To address this aim, 25 patients with major depressive disorder and 35 healthy controls will be assessed twice with magnetic resonance imaging, once after administration of intravenous ketamine (subanesthetic dose) and once after administration of placebo.This study has a single-center, placebo-controlled, cross-over study design. During MRI, structural, resting state, and functional imaging will be performed. Functional imaging will comprise aesthetic processing, reward, and sexual arousal paradigms. In addition, various neuropsychological scales assessing depressive symptoms, anhedonia, and aesthetic processing will be performed. Eligibility for participation will be assessed during a screening visit, a follow up visit will end study participation.
- Conditions
- Major Depressive Disorder
- Being tested
- Ketamine, Placebo
- 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.
KetamineDrug
0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study
PlaceboDrug
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Ketamine first, then placebo | Experimental | 0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study, then placebo Receives: Drug: Ketamine; Drug: Placebo |
| Placebo frist, then ketamine | Experimental | 0.9% NaCl, then ketamine Receives: Drug: Ketamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal assessed with fMRI during aesthetic paradigm
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during an aesthetic processing task
Measured: Change from baseline to up to 4 weeks
BOLD signal assessed with fMRI during reward paradigm
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a reward processing task
Measured: Change from baseline to up to 4 weeks
BOLD signal assessed with fMRI during sexual arousal paradigm
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a sexual arousal paradigm
Measured: Change from baseline to up to 4 weeks
Levels of pleasantness assessed during aesthetic fMRI task
Level of pleasantness (Numbered scale) of aesthetic stimuli during aesthetic paradigm task
Measured: Change from baseline to up to 4 weeks
Number of of chills assessed during aesthetic fMRI task
Number of chills in response to aesthetic stimuli during aesthetic paradigm task
Measured: Change from baseline to up to 4 weeks
BOLD signal assessed with fMRI during resting state
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during resting state
Measured: Change from baseline to up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Jun 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT05320107
- Sponsor's protocol ID
- PSY-NIL-0010
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klobl M, Liebe T, Dorl G, Stohrmann P, Schmidt C, Briem E, Milz C, Schlosser G, Kathofer M, Gomola D, Godbersen GM, Crone JS, Lanzenberger R, Spies M. Sex, drugs, and arousal-two randomized trials on the effects of ketamine on sexual arousal and calcarine gyrus activity. Ther Adv Psychopharmacol. 2026 Feb 12;16:20451253251406059. doi: 10.1177/20451253251406059. eCollection 2026.
PubMed 41693798
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Aesthetic Mind in Anhedonia, Insights From Pharmacological Imaging of the Human Brain: A Single-blind, Randomized, Placebo-controlled Cross-over Study
- ClinicalTrials.gov ID
- NCT05320107
- Acronym / sponsor ID
- PSY-NIL-0010
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 11 Apr 2022 (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 aim of this study is to assess the impact of ketamine on aesthetic perception and processing. This study assesses the role of these effects in facilitating ketamine's antidepressant properties, with a focus on anhedonia. To address this aim, 25 patients with major depressive disorder and 35 healthy controls will be assessed twice with magnetic resonance imaging, once after administration of intravenous ketamine (subanesthetic dose) and once after administration of placebo.This study has a single-center, placebo-controlled, cross-over study design. During MRI, structural, resting state, and functional imaging will be performed. Functional imaging will comprise aesthetic processing, reward, and sexual arousal paradigms. In addition, various neuropsychological scales assessing depressive symptoms, anhedonia, and aesthetic processing will be performed. Eligibility for participation will be assessed during a screening visit, a follow up visit will end study participation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine first, then placebo | Experimental | Drug: Ketamine, Drug: Placebo0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study, then placebo |
| Placebo frist, then ketamine | Experimental | Drug: Ketamine, Drug: Placebo0.9% NaCl, then ketamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- General health based on medical history and physical examination
- Psychiatric health based on structured clinical interview for DSM-5 (SCID) for healthy controls
- Major depressive episode (first or recurrent) based on structured clinical interview for DSM-5 and ICD-10 for patients
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of lefthanded subjects)
Key exclusion criteria (9 listed)
- Current or history of neurological disease
- Current medical illness requiring treatment
- Psychiatric diagnosis for healthy individuals
- Psychiatric comorbidity with the exception of anxiety disorders for depressed individuals
- Pregnancy or current breastfeeding
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 |
|---|---|---|
| Ketamine0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study | Drug | Ketamine first, then placebo, Placebo frist, then ketamine |
| Placebo0.9% NaCl | Drug | Ketamine first, then placebo, Placebo frist, then ketamine |
Primary outcome
BOLD signal assessed with fMRI during aesthetic paradigm
Time frame: Change from baseline to up to 4 weeks
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during an aesthetic processing task
BOLD signal assessed with fMRI during reward paradigm
Time frame: Change from baseline to up to 4 weeks
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a reward processing task
BOLD signal assessed with fMRI during sexual arousal paradigm
Time frame: Change from baseline to up to 4 weeks
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a sexual arousal paradigm
Levels of pleasantness assessed during aesthetic fMRI task
Time frame: Change from baseline to up to 4 weeks
Level of pleasantness (Numbered scale) of aesthetic stimuli during aesthetic paradigm task
Number of of chills assessed during aesthetic fMRI task
Time frame: Change from baseline to up to 4 weeks
Number of chills in response to aesthetic stimuli during aesthetic paradigm task
BOLD signal assessed with fMRI during resting state
Time frame: Change from baseline to up to 4 weeks
Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during resting state
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 41693798Klobl M, Liebe T, Dorl G, Stohrmann P, Schmidt C, Briem E, Milz C, Schlosser G, Kathofer M, Gomola D, Godbersen GM, Crone JS, Lanzenberger R, Spies M. Sex, drugs, and arousal-two randomized trials on the effects of ketamine on sexual arousal and calcarine gyrus activity. Ther Adv Psychopharmacol. 2026 Feb 12;16:20451253251406059. doi: 10.1177/20451253251406059. eCollection 2026.
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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 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 6 inclusion and 9 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 15 Apr 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, MD (0043 1 40400 ext. 35760, 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?
BOLD signal assessed with fMRI during aesthetic paradigm (time frame: Change from baseline to up to 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320107, which also lists 1 linked publication.
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 15 Apr 2024.