Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
12
Countries
1
Sites
1
major depressive disorder (MDD)
Key facts
- Sponsor
- Centre for Human Drug Research
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 10 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-06
- 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 (MDD)
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
- Gabriel Jacobs
Public contact point
- Organisation
- Centre for Human Drug Research
- Contact name
- Gabriel Jacobs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Temporarily halted | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Psychiatry, Zernikedreef 8, 2333 CL, Leiden
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 | 2025-06-10 | 2025-06-23 | 2025-11-14 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-107512
- Halt date
- 2025-11-14
- Member states concerned
- Netherlands
- Publication date
- 2025-11-21
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The study was halted due to tolerability concerns as a result of several participants requesting infusion discontinuation.
- Follow-up measures
- • Unblinding of participants who requested infusion discontinuation
• Conducting a risk assessment for the unblinded participants
• Scheduling FU assessments for participants with occasion cancellation as per the study protocol - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-22 | Netherlands | Acceptable 2025-06-05
|
2025-06-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-05 | Netherlands | Acceptable 2025-06-05
|
2025-08-05 |