A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DT-101, Placebo.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed description
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.
Interventions
- Drug DT-101
DT-101 - Drug Placebo
Placebo
Primary outcome measures
- Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56 [Time frame: from enrolment to day 56]
Secondary outcome measures (1)
- Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 56 [Time frame: from enrolment to day 56]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 17 centers
- Draig Clinical Site — Phoenix
- Draig Clinical Site — Little Rock
- Draig Clinical Site — Costa Mesa
- Draig Clinical Site — Lafayette
- Draig Clinical Site — Hialeah
- Draig Clinical Site — Orlando
- Draig Clinical Site — Orlando
- Draig Clinical Site — Tampa
- … and 9 more centers
Identifiers
NCT: NCT07610473 · DT-101/202