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

RecruitingPhase 2

Sponsor: Draig Therapeutics Ltd

Conditions: Major Depressive Disorder (MDD)

Interventions: DT-101, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (11)

Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Lafayette, California, United States
Hialeah, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
New York, New York, United States
New York, New York, United States
Media, Pennsylvania, United States
DeSoto, Texas, United States