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Taking people in PolandPhase 2

Tests DT-101 in adults with major depressive disorder

Compares different doses of DT-101 with placebo for depressive symptoms in adults.

Key facts

Who runs it
Draig Therapeutics Limited
Where
Gdansk, Katowice, Poznan, and Suchy Las, PolandSee the 5 sitesAlso in 2 other countries, 11 sites
Registry title
DT-101 in Adults with Major Depressive Disorder
Status
Recruiting
Phase
Phase 2
People taking part
175 people, planned
Started
24 Mar 2026
Expected to end
6 Sept 2027
Type of study
Interventional
Record updated
17 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with major depression that has come back at least once. The current episode must have lasted at least 6 weeks.

Age
18 to 65 years
Sex
All sexes and gender identities can join.
Disease stage
Recurrent major depression: at least one earlier episode besides the current one, diagnosed by DSM 5-TR. The current episode has lasted at least 6 weeks before screening.
Earlier treatment
No investigational product within 24 weeks before screening. No St John's wort from 14 days before the first dose until the last dose.

Main reasons for not taking part

  • Cannot follow the study rules, in the investigator's opinion
  • Received an investigational product within 24 weeks before screening
  • Used St John's wort within 14 days before the first dose
  • Gave more than 400 mL of blood within 2 months before screening
  • Gave more than 50 mL of plasma within 30 days before screening

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Poland

Also in 2 other countries, 11 sites

  • Centrum Badan Klinicznych PI-House sp. z o.o.Gdansk, PolandTaking people
  • Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
  • Clinical Medical Research Sp. z o.o.Katowice, PolandTaking people
  • Centrum Medyczne HCP Sp. z o.o.Poznan, PolandTaking people
  • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger MolendaSuchy Las, PolandTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests DT-101 in adults with major depressive disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
17 August 2026