Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
Major depressive disorder
Key facts
- Sponsor
- Centre for Human Drug Research
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- completed 3 Dec 2024
- Decision date (initial)
- 2024-05-17
- 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre for Human Drug Research
- Sponsor organisation
- Centre for Human Drug Research
- Address
- Zernikedreef 8
- City
- Leiden
- Postcode
- 2333 CL
- Country
- Netherlands
Scientific contact point
- Organisation
- Centre for Human Drug Research
- Contact name
- Principal investigator
Public contact point
- Organisation
- Centre for Human Drug Research
- Contact name
- Principal investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Psychiatry, Zernikedreef 8, 2333 CL, Leiden
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-04 | Netherlands | Acceptable 2024-05-17
|
2024-05-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-19 | Netherlands | Acceptable 2024-05-17
|
2024-07-19 |