Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
65
Countries
1
Sites
1
Major Depressive Disorder
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03], Psychiatry and Psychology [F] - Psychological Phenomena [F02], Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
- Trial duration
- 12 Nov 2025 → ongoing
- Decision date (initial)
- 2025-04-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Major Depressive Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10054976 | Antidepressant therapy | 100000004865 |
| 24.0 | LLT | 10056941 | MRI brain | 10022891 |
| 20.0 | LLT | 10027942 | Mood depression | 10037175 |
| 23.0 | LLT | 10083288 | Clinical depression | 10037175 |
| 20.0 | PT | 10002511 | Anhedonia | 100000004873 |
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 | 65 | 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 | 2025-11-12 | 2025-11-12 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-03 | Austria | Acceptable 2025-04-07
|
2025-04-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-10 | Austria | Acceptable 2025-04-07
|
2025-09-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-09 | Austria | Acceptable 2026-04-07
|
2026-04-12 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-27 | Austria | Acceptable 2026-04-07
|
2026-05-27 |