Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
336
Countries
3
Sites
15
Major Depressive Disorder
To assess the effects of different dose levels of the study medicine DT-101 and placebo in the treatment of depressive symptoms in people with MDD.
Key facts
- Sponsor
- Draig Therapeutics Limited
- 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
- 24 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Draig Therapeutics Ltd
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacogenetic, Safety, Therapy, Pharmacodynamic, Pharmacokinetic
To assess the effects of different dose levels of the study medicine DT-101 and placebo in the treatment of depressive symptoms in people with MDD.
Conditions and MedDRA coding
Major Depressive Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10057840 | Major depression | 100000004873 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Randomization
|
Randomised Controlled | Double | [{"id":187648,"code":1,"name":"Subject"},{"id":187650,"code":3,"name":"Monitor"},{"id":187651,"code":4,"name":"Analyst"},{"id":187649,"code":2,"name":"Investigator"}] | Treatment Arm A: - Treatment Arm B: - Treatment Arm C: - |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 1. The participant is able to understand and willing to provide written informed consent.
- 2. Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 65 years of age, inclusive at the time of signing the informed consent.
- 3. Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022). The current episode needs to be at least 6 weeks in duration prior to the screening visit.
Exclusion criteria 4
- 13. In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
- 15. Receipt of any investigational product within 24 weeks prior to Screening.
- 16. Use of St John’s wort is prohibited within 14 days before administration of the first dose of investigational product on Day 1 (Baseline) until last dose of study medication.
- 19. Blood donation or draw in excess of 400 mL within 2 months prior to Screening or plasma donation in excess of 50 mL within 30 days prior to Screening and through the duration of the study. Please refer to the study protocol for full list of exclusion criteria.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- This will be assessed by reviewing the change in the participants score of the depression rating scale called Montgomery Åsberg Depression Rating Scale (MADRS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD12635217 · Product
- Active substance
- DT-101
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0.00 mg milligram(s)
- Max total dose
- 0.00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- DRAIG THERAPEUTICS LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12635218 · Product
- Active substance
- DT-101
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0.00 mg milligram(s)
- Max total dose
- 0.00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- DRAIG THERAPEUTICS LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Matching placebo capsule for PO administration
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Draig Therapeutics Limited
- Sponsor organisation
- Draig Therapeutics Limited
- Address
- Sbarc Spark, Maindy Road Maindy Road
- City
- Cardiff
- Postcode
- CF24 4HQ
- Country
- United Kingdom
Scientific contact point
- Organisation
- Draig Therapeutics Limited
- Contact name
- Draig Therapeutics Ltd
Public contact point
- Organisation
- Draig Therapeutics Limited
- Contact name
- Draig Therapeutics Ltd
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
Locations
3 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 38 | 7 |
| Czechia | Ongoing, recruiting | 38 | 3 |
| Poland | Authorised, recruiting | 37 | 5 |
| Rest of world
United States, United Kingdom
|
— | 223 | — |
Investigational sites
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Clinical Psychiatry, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD
Department of Psychiatry, Ulitsa Starozagorska 16, 6102, Kazanlik
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
N/A, Ulitsa Dimitir Manov 17, 1408, Sofiya
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Mental Health Center Sofia EOOD
Department of active treatment of persons with severe mental disorders - Psychiatry, Bulevard Slivnitsa 309, 1202, Sofia
Center For Mental Health Vratsa EOOD
Department of General Psychiatry, Belasita Str 1, 3000, Vratsa
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
N/A, Ulitsa Dr Lyuben Rusev 1, 1113, Sofia
Psychiatrie Ricany s.r.o.
N/A, Bezrucova 296/22, 251 01, Ricany
MPMeditrine s.r.o.
N/A, Opavska 962/39, 708 00, Poruba
Clintrial s.r.o.
N/A, Pocernicka 1427/16, Strasnice, Prague 10
Uniwersyteckie Centrum Kliniczne
Klinika Psychiatrii Dorosłych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Clinical Medical Research Sp. z o.o.
CLINICAL MEDICAL RESEARCH KORFANTEGO - AMBULATORYJNA OPIEKA SPECJALISTYCZNA, Aleja Wojciecha Korfantego 138, 40-156, Katowice
Centrum Medyczne Hcp Sp. z o.o.
N/A, Ul. 28 Czerwca 1956 R. 194, 61-485, Poznan
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda
N/A, ul. Szkółkarska 32, 62-002, Suchy Las
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 | 2026-03-31 | 2026-05-13 | |||
| Czechia | 2026-03-24 | 2026-04-30 | |||
| Poland | 2026-05-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 29 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522784-15-00_redacted | 1.3 |
| Recruitment arrangements (for publication) | K1_BG_Recruitment Procedure_Bulgarian | 1.2 |
| Recruitment arrangements (for publication) | K1_CZ_Recruitment Procedure_Bilingual | 1.0 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment Procedure_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_Bulgarian_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnancy Data Collection | 1.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnancy Data Collection_Bulgarian | 1.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_VCT_EU 2021-6-N-c_Bilingual | N/A |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Caregiver_Czech_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Data Privacy_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Optional Genetic Research_Czech_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnancy Data Collection_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_VCT_Bilingual_EU 2021-6-N-c | N/A |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Caregiver_Polish_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnancy_Polish | 1.0 |
| Subject information and informed consent form (for publication) | L2_BG_Other subject materials_Patient Daily Diary_Bulgarian | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_GP letter_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Patient Card_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_CZ_Other subject material_Patient Daily Diary_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L2_PL_Other Subject Material_VCT ICF_Polish | N/A |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522784-15-00_Bulgarian_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522784-15-00_Czech_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522784-15-00_Polish_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522784-15-00_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522784-15-00_Bulgarian_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522784-15-00_Czech_redacted | 1.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-16 | Poland | Acceptable 2026-02-23
|
2026-02-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-13 | Poland | Acceptable | 2026-04-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-22 | Acceptable 2026-02-23
|
2026-05-22 |