A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depre… (NCT07610473) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
United States118 participantsStarted 2026-05
Plain-language summary
In this study, researchers will learn more about a study drug called DT-101 in participants with Major Depressive Disorder (MDD), a form of depression. The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. A placebo looks the drug but contains no medicine. Subjects will attend the clinic for complete general health checks and to complete questionnaires.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The participant is able to read, understand and communicate in the local language used at the study site, and is willing to provide written informed consent Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 75 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).
Exclusion Criteria:
Pregnant or breastfeeding or plans to become pregnant during the study. Unstable medical condition or unstable chronic disease. Significant neurological abnormality. History of moderate or severe alcohol or drug use disorder as per DSM-5-TR in the 6 months prior to Screening.
History of seizure. In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since DT-101 is being tested in a Phase 2 trial, what do we know so far about its safety profile, and what unknowns should I be aware of before considering it?
2This trial measures changes in depression symptoms at Day 56 using the MADRS scale — does that 8-week timeline fit with how urgently I need symptom relief right now?
3Because DT-101 is described as an 'adjunctive' treatment, does that mean I would need to stay on my current antidepressant at the same time, and is that something that works with my treatment plan?
4Would starting this trial mean delaying or replacing any standard treatments for my depression that you might otherwise recommend, and how do you weigh those options for my situation?
5What would you expect to happen to my care if I enroll and the trial ends, or if DT-101 doesn't show enough improvement in my MADRS scores by Day 56?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56