Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
72
Countries
1
Sites
1
Incomplete Response - Major Depressive Disorder (IR-MDD)
Key facts
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 17 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-31
- 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
Incomplete Response - Major Depressive Disorder (IR-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
Otsuka Pharmaceutical Development & Commercialization Inc.
- Sponsor organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Address
- 2440 Research Boulevard
- City
- Rockville
- Postcode
- 20850-3238
- Country
- United States
Scientific contact point
- Organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Contact name
- EU Clinical Trials Helpdesk
Public contact point
- Organisation
- Otsuka Pharmaceutical Development & Commercialization Inc.
- Contact name
- EU Clinical Trials Helpdesk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Temporarily halted | 72 | 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 | 2025-11-17 | 2025-11-17 | 2026-05-27 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-137976
- Halt date
- 2026-05-27
- Member states concerned
- Netherlands
- Publication date
- 2026-06-09
- Reason
- Sponsor decision
- Explanation
- The Dose Review Committee (DRC) meeting occurred on 27-May for Cohort 2. Although the data reviewed showed no safety concerns and the study drug appeared to be well tolerated, indicating a benefit/risk profile supportive of dose increases for Cohort 3, one participant in the 3.0 mg EEG Part 1 had a pharmacokinetics AUCt value ≥ 63.5 h*ng/mL for MSP-2019. This met a protocol stopping criterion resulting in a temporary study halt of further dose escalation.
- Follow-up measures
- Not applicable, at the time of halt, the latest cohort has completed and no patients are active.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-22 | Netherlands | Acceptable 2025-10-31
|
2025-10-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-03 | Netherlands | Acceptable 2025-10-31
|
2025-12-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-20 | Netherlands | Acceptable 2025-10-31
|
2026-01-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-27 | Netherlands | Acceptable 2026-05-13
|
2026-05-13 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-27 | Netherlands | Acceptable 2026-05-13
|
2026-05-27 |