NCT07300969 A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
| NCT ID | NCT07300969 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Draig Therapeutics Ltd |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2025-12-16 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07300969 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07300969 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07300969 currently recruiting?
Yes, NCT07300969 is actively recruiting participants. Contact the research team at info@draigtherapeutics.com for enrollment information.
Where is the NCT07300969 trial being conducted?
This trial is being conducted at Bentonville, United States, Little Rock, United States, Oceanside, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT07300969 clinical trial?
NCT07300969 is sponsored by Draig Therapeutics Ltd. The trial plans to enroll 300 participants.