#1 Clinical Trials Search in Europe

A study to evaluate the effectiveness and safety of DT-101 in adults with major depressive disorder

1

What is this study about?

This study focuses on Major Depressive Disorder, a mental health condition characterized by persistent feelings of sadness and a loss of interest in daily activities. The purpose of the study is to evaluate the effects of different dose levels of the experimental medicine DT-101 compared to a placebo in treating symptoms of this condition.

Participants in the study will take a capsule by mouth. During the trial, some individuals will receive the active substance DT-101, while others will receive a placebo. This research will examine how the medicine works in the body and its safety profile over time.

Who Can Join the Study?

  • You must be able to understand the study details and be willing to sign a written informed consent, which is a formal document where you agree to participate after being told all the facts.
  • You must be a male or female between the ages of 18 and 65 at the time you agree to join the study.
  • You must have a diagnosis of recurrent depression, which means you have experienced at least one previous period of depression in the past, in addition to your current one.
  • Your current period of depression must have lasted for at least 6 weeks before your first screening visit.
  • Your diagnosis must be confirmed using the DSM-5-TR, which is the standard manual used by doctors to identify and classify mental health conditions.

Who Cannot Join the Study?

  • If the investigator (the main doctor in charge of the study) believes you will not be able to follow all the rules and steps of the study.
  • If you have taken any investigational product (a medicine that is being tested and is not yet fully approved) in the 24 weeks before starting the screening process.
  • If you use St John’s wort (a herbal supplement often used for mood) within 14 days before your first dose or while you are taking the study medicine.
  • If you have donated more than 400 mL of blood (the red liquid that carries oxygen through your body) in the 2 months before the screening.
  • If you have donated more than 50 mL of plasma (the yellowish liquid part of the blood) within 30 days before the screening or during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda Suchy Las Poland

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
Clinical Medical Research Sp. z o.o. Katowice Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Clintrial s.r.o. Prague Czechia
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Sofia Bulgaria
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD Kazanlak Bulgaria
Cvwdxcm Blqmu Kpxdznducyq Phsakrxz Siv z oueg Gdansk Poland
Myxiwsxoxot septxx Poruba Czechia
Ppnonvsvhjr Ricjlp swdkti Ricany Czechia
Midmwn Hnbmzg Canjlf Sfxmg Ezkw Sofia Bulgaria
Cpmwhp Fbk Mcktfh Hjltyt Vpylbk Etcn Vratsa Bulgaria
Uovnlcyekmzjtb Cfbhpwj Kqtdjgqoc Gdansk Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
14.02.2026
Czechia Czechia
Recruiting
14.02.2026
Poland Poland
Recruiting
14.02.2026

Trial locations

DT-101 is an experimental medicine taken by mouth in capsule form that is being studied to see if it can help improve symptoms in adults living with major depressive disorder.

Investigated diseases:

Major Depressive Disorder – This condition is a mental health disorder characterized by a persistent feeling of sadness or a loss of interest in activities once enjoyed. It involves changes in mood, thoughts, and physical sensations that interfere with daily life. The symptoms can vary in severity and may change over time. Progress can involve periods of intense emotional distress followed by periods of relative stability. Over time, the pattern of symptoms may fluctuate or become more constant.

Trial ID:
2025-522784-15-00
Protocol code:
DT-101/201
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Assessment of NBI-1065845 as an Additional Treatment for Adults with Major Depressive Disorder

    Recruiting

    1 1
    Investigated drugs:
    Bulgaria Lithuania Romania Slovakia

  • Evaluating NBI-1065845 as an Additional Treatment for Adults with Major Depressive Disorder Who Are Not Responding Adequately to Current Therapy

    Recruiting

    1 1
    Investigated drugs:
    Belgium Finland Hungary Latvia