A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression

Summary

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.

Eligibility

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.

Conditions2

Interventions1

Locations2 sites

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• A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression — Draig Therapeutics Ltd

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