Clinical trial • Phase II • Psychiatry

DT-101 for Major depressive disorder

Phase II trial of DT-101 for Major depressive disorder.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Major depressive disorder
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-10-2025
First CTIS Authorization Date
24-02-2026

Trial design

Randomised, matching placebo capsule for oral (po) administration (matching placebo); active investigational product: dt-101 (oral capsule). doses/schedules not specified in available data.-controlled Phase II trial across 15 sites in Bulgaria, Czechia, Poland.

Randomised
Yes
Comparator
Matching placebo capsule for oral (PO) administration (matching placebo); active investigational product: DT-101 (oral capsule). Doses/schedules not specified in available data.
Target Sample Size
223

Eligibility

Recruits 223 Vulnerable population selected. Participants must be able to understand and be willing to provide written informed consent ("The participant is able to understand and willing to provide written informed consent"). Caregiver consent/involvement materials are included in provided documents (e.g. 'L1_CZ_SIS-ICF_Caregiver_Czech_redacted', 'L1_PL_SIS-ICF_Caregiver_Polish_redacted'), indicating caregiver/representative procedures where applicable..

Vulnerable Population
Vulnerable population selected. Participants must be able to understand and be willing to provide written informed consent ("The participant is able to understand and willing to provide written informed consent"). Caregiver consent/involvement materials are included in provided documents (e.g. 'L1_CZ_SIS-ICF_Caregiver_Czech_redacted', 'L1_PL_SIS-ICF_Caregiver_Polish_redacted'), indicating caregiver/representative procedures where applicable.

Inclusion criteria

  • {"criterion_text":"- 1.\tThe participant is able to understand and willing to provide written informed consent.\n- 2.\tMale 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.\n- 3.\tHas 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

  • {"criterion_text":"- 13. In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.\n- 15. Receipt of any investigational product within 24 weeks prior to Screening.\n- 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.\n- 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 endpoints

  • {"endpoint_text":"- This will be assessed by reviewing the change in the participants score of the depression rating scale called Montgomery Åsberg Depression Rating Scale (MADRS)","definition_or_measurement_approach":"Change in participants' score on the Montgomery Åsberg Depression Rating Scale (MADRS) (assessed by reviewing the change in the participant's MADRS score)."}

Recruitment

Planned Sample Size
223
Recruitment Window Months
18
Consent Approach
Written informed consent required from participant. Eligible participants are adults (18-65 years) and must provide written informed consent. Caregiver consent/ICF documents are present for some countries (e.g. Czech and Poland caregiver ICFs). Subject information and informed consent forms are provided in multiple country languages (Bulgarian, Czech, Polish) and bilingual EU versions as indicated by document titles.

Geography

Total Number Of Sites
15
Total Number Of Participants
113

Bulgaria

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
9
Number Of Sites
7
Number Of Participants
38

Sites

Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Clinical Psychiatry
Contact Person Name
Andriana Kakanakova
Site Name
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD
Department Name
Department of Psychiatry
Contact Person Name
Ivan Dimitrov
Contact Person Email
itdim@abv.bg
Site Name
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
Contact Person Name
Petya Dimitrova
Contact Person Email
drdimitrova@abv.bg
Site Name
Medical Center Hera EOOD
Contact Person Name
Spiridon Spiridonov
Contact Person Email
spiridon.aleksiev@gmail.com
Site Name
Mental Health Center Sofia EOOD
Department Name
Department of active treatment of persons with severe mental disorders - Psychiatry
Contact Person Name
Emil Grashnov
Contact Person Email
dr.emo@mail.bg
Site Name
Center For Mental Health Vratsa EOOD
Department Name
Department of General Psychiatry
Contact Person Name
Nadya Ivanova
Contact Person Email
nadia_odpzs@abv.bg
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Contact Person Name
Assen Karadaliev
Contact Person Email
karadaliev@hotmail.com

Czechia

Earliest CTIS Part Ii Submission Date
19-02-2026
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
5
Number Of Sites
3
Number Of Participants
38

Sites

Site Name
Clintrial s.r.o.
Contact Person Name
Zdeněk Šolle
Contact Person Email
zdenek.solle@clintrial.cz
Site Name
MPMeditrine s.r.o.
Contact Person Name
Marek Pérez
Contact Person Email
marek.perez@centrum.cz
Site Name
Psychiatrie Ricany s.r.o.
Contact Person Name
Jan Čermák
Contact Person Email
cermak@psychiatrie-ricany.cz

Poland

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
73
Number Of Sites
5
Number Of Participants
37

Sites

Site Name
Clinical Medical Research Sp. z o.o.
Department Name
CLINICAL MEDICAL RESEARCH KORFANTEGO - AMBULATORYJNA OPIEKA SPECJALISTYCZNA
Contact Person Name
Anna Szczegielniak
Site Name
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda
Contact Person Name
Agnieszka Remlinger-Molenda
Contact Person Email
aremlinger@gmail.com
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Hanna Badzio-Jagiełło
Contact Person Email
pihouse@pihouse.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Psychiatrii Dorosłych
Contact Person Name
Wiesław Jerzy Cubała
Contact Person Email
cubala@gumed.edu.pl
Site Name
Centrum Medyczne Hcp Sp. z o.o.
Contact Person Name
Sylwia Szymkowiak
Contact Person Email
badania.kliniczne@cmhcp.pl

Sponsor

Primary sponsor

Full Name
Draig Therapeutics Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
CRO

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
DT-101
Active Substance
DT-101
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
UK MIA(IMP) 20377 (prodAuthStatus=1)
Investigational Product Name
Matching placebo capsule for PO administration
Modality
Other
Authorisation Status
UK MIA(IMP) 20377

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