Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
230
Countries
1
Sites
4
The intended indication is for the treatment of major depressive disorder.
Key facts
- Sponsor
- CCDRD Cooperative Clinical Drug Research and Development AG, Corium Innovations 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
- 30 Jun 2026 → ongoing
- Decision date (initial)
- 2026-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2026-525269-34-00
- ClinicalTrials.gov
- NCT07452692
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
The intended indication is for the treatment of major depressive disorder.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081270 | Major depressive disorder | 10037175 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CCDRD Cooperative Clinical Drug Research and Development AG
- Sponsor organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Address
- Dahlwitz, Lindenallee 70, Dahlwitz-Hoppegarten Lindenallee 70 Dahlwitz-Hoppegarten
- City
- Hoppegarten
- Postcode
- 15366
- Country
- Germany
Scientific contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Rossen Kyotchev, MD, PhD
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Wolfram Richter, MD
Corium Innovations Inc.
- Sponsor organisation
- Corium Innovations Inc.
- Address
- 4558 50th Street Southeast
- City
- Grand Rapids
- Postcode
- 49512-5401
- Country
- United States
Scientific contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Rossen Koytchev, MD, PhD
Public contact point
- Organisation
- CCDRD Cooperative Clinical Drug Research and Development AG
- Contact name
- Wolfram Richter, MD
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 230 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
MHAT Skin Systems EOOD
Department-Elin Pelin- Skin and Venereal Diseases, 15 Zdravets str., 2100, Elin Pelin
Acibadem City Clinic EAD
Clinic of pneumology – pneumology and phtisiatrics, Lozenets Distr. Fl 4, Bulevard Nikola Yonkov Vaptsarov 53, Sofia
Diagnostic Consultative Centre Ascendent EOOD
Bed space for short term stay, Ulitsa Bacho Kiro 47, 1202, Sofia
MC Neovitro OOD
Bed space for short term stay, 75 Bulgaria Blvd., 1404, Sofia
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 |
|---|---|---|---|---|---|
| Bulgaria | 2026-06-30 | 2026-07-06 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-06 | Bulgaria | Acceptable 2026-06-22
|
2026-06-26 |