DT-101 in Adults with Major Depressive Disorder
Key facts
- Where
- Cherven Bryag, Kazanlik, Plovdiv, Sofia, Sofiya és Vratsa, BulgáriaSee the 8 sites
- Phase
- 2. fázis
Where in Bulgária
- Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ETCherven Bryag, BulgáriaTaking people
- Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOODKazanlik, BulgáriaTaking people
- University Multiprofile Hospital For Active Treatment Saint Georgi EADPlovdiv, BulgáriaTaking people
- Mental Health Center Sofia EOODSofia, BulgáriaTaking people
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EADSofia, BulgáriaTaking people
- Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OODSofiya, BulgáriaTaking people
- Medical Center Hera EOODSofiya, BulgáriaTaking people
- Center For Mental Health Vratsa EOODVratsa, BulgáriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Draig Therapeutics Limited
- Trial code
- EU 2025-522784-15-00
- Record updated
- 2026. augusztus 17.
- Original description
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.Read full original descriptionShow less
A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults with 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.
Inclusion: The participant is able to understand and willing to provide written informed consent; 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; 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: Receipt of any investigational product within 24 weeks prior to Screening; 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; 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; In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.