Ketamine TreatmentPhase 1NCT05320120
Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI
A Phase 1 study testing 56mg esketamine (2x Spravato® 28 mg nasal spray) and 0.9% saline solution nasal spray in people with Ketamine Treatment, run by Rupert Lanzenberger at 1 site in Austria.
Trial summary
Subanesthetic ketamine is currently used as a rapid-acting antidepressant. It is an antagonist of the N-methyl-d-aspartate (NMDA) receptor, but former results indicate that its action also depends on the noradrenaline system and the locus coeruleus (LC). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketamine Treatment
- What is being tested?
- 56mg esketamine (2x Spravato® 28 mg nasal spray) and 0.9% saline solution nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2022to 21 Jun 2023
- 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 (no serious internal or neurologic pre-existing conditions) based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of left-handed 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
- Current or former substance abuse
- Pregnancy or current breastfeeding
- Diagnosis of an Axis-1 psychotic disorder in a first-degree relative
- Known aneurysmal vascular disease based on medical history (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), history of intracerebral haemorrhage, recent (within 6weeks) cardiovascular event, including myocardial infarction (MI)
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- Significant pulmonary insufficiency, including COPD; sleep apnoea with morbid obesity (BMI ≥35), uncontrolled brady- or tachyarrhythmias that lead to haemodynamic instability; history of an MI, haemodynamically significant valvular heart disease or heart failure (NYHA Class III-IV)
- Hyperthyroidism that has not been sufficiently treated
- History of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure
- Child-Pugh class C (severe) hepatic impairment
- 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.
About this study
Official title: Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI: a Placebo Controlled, Randomized, Cross-over Trial
Subanesthetic ketamine is currently used as a rapid-acting antidepressant. It is an antagonist of the N-methyl-d-aspartate (NMDA) receptor, but former results indicate that its action also depends on the noradrenaline system and the locus coeruleus (LC).
Based on this known impact of ketamine on the sympathetic nervous system the aim of this study is to investigate the effects of intranasal esketamine on LC related attentional brain networks in task based functional MRI, to relate those attention network changes to behavioural measures and to predict ketamine related attention network changes by brain structure.
- Conditions
- Ketamine Treatment
- Being tested
- 56mg esketamine (2x Spravato® 28 mg nasal spray), 0.9% saline solution nasal spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
56mg esketamine (2x Spravato® 28 mg nasal spray)Drug
56mg esketamine (2x Spravato® 28 mg nasal spray)
0.9% saline solution nasal sprayDrug
0.9% saline solution nasal spray
| Study group | Role | What they receive |
|---|---|---|
| first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo | Experimental | Not described Receives: Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray); Drug: 0.9% saline solution nasal spray |
| first placebo (0.9% saline solution nasal spray), then ketamine | Experimental | Not described Receives: Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray); Drug: 0.9% saline solution nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD response assessed with fMRI to arousal task
Blood oxygen level (BOLD) response assessed with functional magnetic resonance imaging (fMRI) during an arousal task
Measured: up to two 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 completion21 Jun 2023
- Study completion21 Jun 2023
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 Ketamine TreatmentStudies of the same condition, open and under way.
- 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, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rupert Lanzenberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rupert Lanzenberger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320120
- Sponsor's protocol ID
- PSY-NIL-0011
- Status last verified
- Apr 2024
- First submitted
- 28 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
- Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI: a Placebo Controlled, Randomized, Cross-over Trial
- ClinicalTrials.gov ID
- NCT05320120
- Acronym / sponsor ID
- PSY-NIL-0011
- Conditions
- Ketamine Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Rupert LanzenbergerUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- 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.
Subanesthetic ketamine is currently used as a rapid-acting antidepressant. It is an antagonist of the N-methyl-d-aspartate (NMDA) receptor, but former results indicate that its action also depends on the noradrenaline system and the locus coeruleus (LC).
Based on this known impact of ketamine on the sympathetic nervous system the aim of this study is to investigate the effects of intranasal esketamine on LC related attentional brain networks in task based functional MRI, to relate those attention network changes to behavioural measures and to predict ketamine related attention network changes by brain structure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo | Experimental | Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray), Drug: 0.9% saline solution nasal spray |
| first placebo (0.9% saline solution nasal spray), then ketamine | Experimental | Drug: 56mg esketamine (2x Spravato® 28 mg nasal spray), Drug: 0.9% saline solution nasal spray |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- General health (no serious internal or neurologic pre-existing conditions) based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of left-handed subjects)
- Willingness and competence to sign the informed consent form
Key exclusion criteria (12 listed)
- Current or history of psychiatric or neurological disease
- Current medical illness requiring treatment
- Current or former substance abuse
- Pregnancy or current breastfeeding
- 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 |
|---|---|---|
| 56mg esketamine (2x Spravato® 28 mg nasal spray)56mg esketamine (2x Spravato® 28 mg nasal spray) | Drug | first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo, first placebo (0.9% saline solution nasal spray), then ketamine |
| 0.9% saline solution nasal spray0.9% saline solution nasal spray | Drug | first 56mg esketamine (2x Spravato® 28 mg nasal spray), then placebo, first placebo (0.9% saline solution nasal spray), then ketamine |
Primary outcome
BOLD response assessed with fMRI to arousal task
Time frame: up to two weeks
Blood oxygen level (BOLD) response assessed with functional magnetic resonance imaging (fMRI) during an arousal task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 56mg esketamine (2x Spravato® 28 mg nasal spray) and 0.9% saline solution nasal spray in people with Ketamine Treatment, run by Rupert Lanzenberger 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 12 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD response assessed with fMRI to arousal task (time frame: up to two weeks). 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 NCT05320120, 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.