NCT07610473RecruitingPhase 2
A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
A Phase 2 Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder Receiving Pharmacological Therapy for Depression
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 21 May 2026
- Start date
- 14 May 2026
- Primary completion date
- May 2027
- Lead sponsor
- Draig Therapeutics Ltd
- Diseases
- Depression
- NCT number
- NCT07610473
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 118
- From 14 May 2026 to the primary completion date, May 2027
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of moderate or severe alcohol or drug use disorder as per DSM-5-TR in the 6 months prior to Screening.
Other illness
- Unstable medical condition or unstable chronic disease.
- History of seizure.
Other
- Pregnant or breastfeeding or plans to become pregnant during the study.
- Significant neurological abnormality.
- In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.