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

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation
After joining the study, you will be assigned to receive either the test medicine, known as dt-101, or a placebo, which is a capsule that contains no active medicine.
The assignment is determined by randomization, which is a process used to ensure the selection is made by chance, and it is double-blind, meaning neither you nor the medical staff will know which substance is being administered during the treatment period.
Step 2
Medication administration
The assigned medicine, either dt-101 or the placebo, is taken as an oral capsule.
Step 3
Evaluation of symptoms
The effectiveness of the treatment is measured by observing changes in symptoms of major depressive disorder, which is a condition characterized by persistent feelings of sadness and loss of interest.
The changes are tracked using a specific tool called the montgomery åsberg depression rating scale (madrs), which is a questionnaire used to assess the severity of depressive symptoms.

Who can join the trial?

5 criteria

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 trial?

5 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Verified
Clintrial s.r.o.
Prague, Czechia
Responsive
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

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.

What is already known about the treatment

DT-101
This medication is taken by mouth in the form of a capsule and is currently being studied in clinical trials to determine its effectiveness. It is being investigated as a potential treatment for adults living with major depressive disorder. The substance belongs to an experimental class of drugs that aims to work on specific biological pathways in the brain to improve mood. Once its safety and how it moves through the body are fully understood, it may become a standard option for managing depression.
Matching placebo capsule for PO administration
This is an inactive substance provided in a capsule form to be taken by mouth during the study. It contains no active medicinal ingredients and is used as a comparison to help researchers see if the test drug actually works. In medical research, placebos are essential for ensuring that any improvements seen in patients are due to the medicine itself rather than other factors. It is classified as an inactive control substance used specifically for clinical trial comparison.

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.