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

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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
Clintrial s.r.o.	Prague	Czechia
Mbjlwle Cqiyse Hhqh Ednt	Sofia	Bulgaria
Umnmmyxdoqeynk Cbwefbu Kbvehrsil	Gdansk	Poland
Cmfvpmz Bevno Klfnrviolnn Pejubphc Sze z ofqu	Gdansk	Poland
Uwlnxalkls Mktudgthiomq Hxwzjnbb Fbq Avatxx Tebyqyeyv Sdvmd Gxsqdh Eff	Plovdiv	Bulgaria
Mmuaoymvdlnb Hdpmerit Ftn Agvbke Txgonkqpe Ix Ncwnlbrhg Asr Poqfdbubok Sqz Nysv Ejf	Sofia	Bulgaria
Mssdnlzrwls sqwaxw	Poruba	Czechia
Phetaktaxsy Rqqtjh szlnsx	Ricany	Czechia
Dmhcpsihok Aet Cdkoaqcxuvjz Cppuvl Stzrfwza Afe Scznii Kiodk Ans Dkzzbc Oye	Sofia	Bulgaria
Mxbfslheqqiw Hgpmptsj Fdc Argsqg Tptyazwek Dni Htapym Smogpgjzxc Eaac	Kazanlak	Bulgaria
Cprytyw Mqvcjekz Hml Sia z ongr	Poznan	Poland
Ceecmr Fse Mvgmxy Hkkukh Vnlcde Evxk	Vratsa	Bulgaria
Cmqohkyx Mkfxjce Ryujcxyi Sbo z obuu	Katowice	Poland
Mhpnft Hxnznd Czrqmv Shghz Eeru	Sofia	Bulgaria
Dzy Isq Naqrmh Ovgsmiwawn Ckhxbu Fsz Iqsissadvm Pdkmyqji Frt Snfrrqfjbfp Mobcvoj Cyiv Ix Pxcybeitpx Eo	Cherven Bryag	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	14.02.2026
Czechia	Recruiting	14.02.2026
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 depression

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)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?