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Recruiting
NCT07300969
A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression
Conditions: Major Depressive Disorder (MDD)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 300
Sponsor: Draig Therapeutics Ltd
Location: Draig Clinical Site Bentonville Arkansas
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.
Source: ClinicalTrials.gov (NCT07300969). StuddyBuddy aggregates publicly available trial information.