Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
1
Major Depressive Disorder (MDD)
Key facts
- Sponsor
- Delix Therapeutics Inc., Delix Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 6 Nov 2024 → 6 Jun 2025
- Decision date (initial)
- 2024-11-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Major Depressive Disorder (MDD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081270 | Major depressive disorder | 10037175 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Delix Therapeutics Inc.
- Sponsor organisation
- Delix Therapeutics Inc.
- Address
- 20 Authors Road
- City
- Concord
- Postcode
- 01742-2607
- Country
- United States
Scientific contact point
- Organisation
- Delix Therapeutics Inc.
- Contact name
- Aaron Koenig
Public contact point
- Organisation
- Delix Therapeutics Inc.
- Contact name
- Nicholas Pelletier
Delix Therapeutics Inc.
- Sponsor organisation
- Delix Therapeutics Inc.
- Address
- 36 Crosby Drive Suite 200
- City
- Bedford
- Postcode
- 01730-1442
- Country
- United States
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharma Bio-Research Group
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-11-06 | 2025-06-05 | 2024-11-06 | 2025-05-12 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-10 | Netherlands | Acceptable 2024-11-04
|
2024-11-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-31 | Netherlands | Acceptable 2025-02-05
|
2025-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-27 | Netherlands | Acceptable 2025-03-05
|
2025-03-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-20 | Netherlands | Acceptable 2025-05-27
|
2025-05-27 |