Overview
Sponsor-declared trial summary
Healthy volunteers - no medical condition
Main study: To characterize the effects of ketamine enantiomers on brain activation and metabolism. Pilot I: To obtain behavioral data associated with ketamine application Pilot II: To optimize procedures associated with application of the study medication To demonstrate feasibility of this novel functional PET approac…
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify, Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 17 Jan 2020 → ongoing
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519234-23-00
- EudraCT number
- 2019-003174-11
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
Main study:
To characterize the effects of ketamine enantiomers on brain activation
and metabolism.
Pilot I:
To obtain behavioral data associated with ketamine application
Pilot II:
To optimize procedures associated with application of the study
medication
To demonstrate feasibility of this novel functional PET approach
Secondary objectives 1
- To identify downstream metabolites relevant for antidepressant treatment response
Conditions and MedDRA coding
Healthy volunteers - no medical condition
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - General health 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
Exclusion criteria 1
- - 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 30mSv over the last 10 years must not be exceeded, as specified in the Austrian legislation on radiation protection (Med. Strahlenschutzverordnung 11.01.2011; www.ris.bka.gv.at). Accordingly, body weight >100kg is an exclusion criterion (5.1 MBq/kg * 100kg * 0.019 mSv/Mbq * 0.885 = 8.58mSv 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- regional cerebral metabolic rate of glucose (rCMRGlu), cerebral blood flow (CBF), functional connectivity (FC), Volumen (GMV), mean diffusivity (MD), fractional anisotropy (FA)
Secondary endpoints 1
- Psychopathological effects of administration of the study medication
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Ketanest® S 25 mg/ml - Ampullen
PRD412849 · Product
- Active substance
- Esketamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 0.25 mg/kg milligram(s)/kilogram
- Max total dose
- 0.25 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX14 — ESKETAMINE
- Marketing authorisation
- 1-22525
- MA holder
- PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Off-Label use in healthy volunteers
Ketamin-hameln 50 mg/ml Injektionslösung
PRD3244513 · Product
- Active substance
- Ketamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 0.5 mg/kg milligram(s)/kilogram
- Max total dose
- 0.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX03 — KETAMINE
- Marketing authorisation
- 32265.00.00
- MA holder
- HAMELN PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Off-label use in healthy volunteers
Placebo 1
Saline Solution Basi 9 mg/ml solution for infusion
PRD11121726 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 500 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 5211800
- MA holder
- LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Psychiatry and Psychotherapy, Division of General Psychiatry
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Psychiatry and Psychotherapy, Division of General Psychiatry
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 75 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2020-01-17 | 2020-10-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2019-003174-11 | 2.3 |
| Protocol (for publication) | D1_Protocol 2019-003174-11_redacted | 2.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 5.2 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Ketamin-hameln | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Ketanest | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-30 | Austria | Acceptable 2025-01-30
|
2025-01-30 |