RecruitingPhase 2NCT07300969
A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
A Phase 2 Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder (MDD)
Sponsor
Draig Therapeutics Ltd
Enrollment
300 participants
Start Date
Dec 16, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria3
- 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 Criteria6
- 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.
Interventions
DRUGDT-101
DT-101 A
DRUGDT-101
DT-101 B
DRUGPlacebo
Placebo
Locations(24)
View Full Details on ClinicalTrials.gov
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NCT07300969
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