Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Not authorised
Participants planned
85
Countries
1
Sites
1
Major Depressive Disorder
Key facts
- Sponsor
- Medical University of Vienna
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Psychological Phenomena [F02], Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2024-08-05
- 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 |
|---|---|---|---|---|
| 23.0 | LLT | 10083288 | Clinical depression | 10037175 |
| 24.0 | LLT | 10056941 | MRI brain | 10022891 |
| 20.0 | PT | 10002511 | Anhedonia | 100000004873 |
| 20.0 | LLT | 10027942 | Mood depression | 10037175 |
| 21.1 | PT | 10054976 | Antidepressant therapy | 100000004865 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University of Vienna
- Sponsor organisation
- Medical University of Vienna
- Address
- Waehringer Guertel 18-20, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University of Vienna
- Contact name
- Division of General Psychiatry
Public contact point
- Organisation
- Medical University of Vienna
- Contact name
- Division of General Psychiatry
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Not authorised | 85 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-18 | Austria | Not acceptable 2024-08-05
|
2024-08-05 |