TrialPath
Recruiting

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

NCT07610473 · Draig Therapeutics Ltd
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase 2 Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder Receiving Pharmacological Therapy for Depression
About this study
The purpose of this study is to compare DT-101 and placebo in adult participants with MDD already receiving medication for depression. The clinical study will also evaluate how safe and well tolerated the study drug is. Potential participants will be assessed if they are suitable to take part in the clinical research study by performing physical and neurological examinations, obtaining blood and urine samples, conducting clinical assessments and reviewing medical and treatment history. After successfully passing screening into the study, participants will be randomly assigned to receive either DT-101 or placebo for the study. Over the next 8 weeks, these tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyse the effect that DT-101 may have on their depression symptoms. Participants will also have blood samples taken to allow analysis of how DT-101 is absorbed and used by the body.
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.
Study design
Enrollment target: 118 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-06
Estimated completion: 2027-05
Last updated: 2026-07-17
Interventions
Drug: DT-101Drug: Placebo
Primary outcomes
  • Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56 (from enrolment to day 56)
Sponsor
Draig Therapeutics Ltd · industry
Contacts & investigators
ContactAeron-1 Clinical Team · contact · info@draigtherapeutics.com · +44(0)2920028450
All locations (11)
Draig Clinical SiteRecruiting
Phoenix, Arizona, United States
Draig Clinical SiteRecruiting
Little Rock, Arkansas, United States
Draig Clinical SiteRecruiting
Lafayette, California, United States
Draig Clinical SiteRecruiting
Hialeah, Florida, United States
Draig Clinical SiteRecruiting
Tampa, Florida, United States
Draig Clinical SiteRecruiting
Decatur, Georgia, United States
Draig Clinical SiteRecruiting
Chicago, Illinois, United States
Draig Clinical SiteRecruiting
New York, New York, United States
Draig Clinical SiteRecruiting
New York, New York, United States
Draig Clinical SiteRecruiting
Media, Pennsylvania, United States
Draig Clinical SiteRecruiting
DeSoto, Texas, United States
A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression · TrialPath