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

RECRUITINGPhase 2Sponsored by Draig Therapeutics Ltd
Actively Recruiting
PhasePhase 2
SponsorDraig Therapeutics Ltd
Started2026-06
Est. completion2027-05
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations17 sites

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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

DepressionMajor Depressive Disorder (MDD)

Interventions1

Locations17 sites

Draig Clinical Site
Draig Clinical Site+44(0)2920028450info@draigtherapeutics.com
Draig Clinical Site
Little Rock, Arkansas, 72211
Draig Clinical Site+44(0)2920028450info@draigtherapeutics.com
Draig Clinical Site
Costa Mesa, California, 92626
Draig Clinical Site+44(0)2920028450info@draigtherapeutics.com
Draig Clinical Site
Lafayette, California, 94549
Draig Clinical Site+44(0)2920028450info@draigtherapeutics.com
Draig Clinical Site
Hialeah, Florida, 33016
Draig Clinical Site+44(0)2920028450info@draigtherapeutics.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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