Actively Recruiting
A Phase 2 Randomized, Double-blind, Placebo-controlled Trial Evaluating DT-101 for Adults With Major Depressive Disorder Receiving Medication
Led by Draig Therapeutics Ltd · Updated on 2026-05-28
118
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a study drug called DT-101 in adults diagnosed with Major Depressive Disorder (MDD), a type of depression. This trial aims to compare the effects of DT-101 with a placebo, which looks like the drug but contains no active medicine, to understand if DT-101 can help treat depression. The study is a Phase 2, double-blind, randomized, placebo-controlled trial that also examines the safety and tolerance of DT-101. Participants who are already receiving medication for depression will be randomly assigned to receive either DT-101 or placebo. The treatment period lasts 8 weeks, during which participants will attend the clinic for ongoing assessments. These include physical and neurological exams, blood and urine samples, and questionnaires to monitor health and collect data on depression symptoms. Blood samples will also be analyzed to study how DT-101 is absorbed and processed by the body. Throughout the study, participants will complete general health checks and clinical assessments to ensure ongoing suitability and collect data on symptom changes. The main outcome measured is the change in the Montgomery Åsberg Depression Rating Scale (MADRS) score from the start to day 56. Safety and severity assessments will also be performed. The total participation duration includes screening and 8 weeks of treatment with regular monitoring.
CONDITIONS
Brief Title
A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and communicate in the local language used at the study site
- Willing to provide written informed consent
- Male or female participant assigned at birth, inclusive of all gender identities
- Aged 18 to 75 years at the time of signing consent
- Diagnosed with recurrent depression by DSM 5-TR criteria, excluding the current episode
You will not qualify if you...
- Pregnant, breastfeeding, or planning 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 in the 6 months before screening
- History of seizure
- Investigator believes participant cannot adhere to protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for physical and neurological examinations, blood and urine samples, and clinical assessments
Duration - 8 weeks
Participants receive either DT-101 or placebo alongside their existing medication for depression. Tests and assessments continue throughout this period to monitor participants' suitability and collect data on the effect of DT-101 on depression symptoms.
Weekly visits for assessments and blood sample collection
Trial Site Locations
Total: 2 locations
1
Draig Clinical Site
DeSoto, Texas, United States, 75115
Actively Recruiting
2
Draig Clinical Site
Miami, Texas, United States, 33166
Actively Recruiting
Research Team
A
Aeron-1 Clinical Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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