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Recruiting NCT07300969

A Study to Evaluate the Effectiveness of DT-101 in Patients With Depression

Phase II Interventional Major Depressive Disorder (MDD)

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, 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, Bulgaria, Czechia, Poland, United Kingdom
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 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder (MDD)

Overview

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. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.

Detailed description

The purpose of this study is to compare DT-101 and placebo in adult participants with MDD. The study will also evaluate how safe and well tolerated the study drug is. The clinical study staff will check participants' suitability 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. These tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyze 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 (PK sampling), some blood samples may be retained in order to perform future research that may be useful when looking at whether genetics affects how a person responds to DT-101 (PGx sampling)

Interventions

  • Drug DT-101
    DT-101 A
  • Drug DT-101
    DT-101 B
  • Drug Placebo
    Placebo

Primary outcome measures

  • Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 42 [Time frame: from enrollment to day 42]
Secondary outcome measures (1)
  • Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 42 [Time frame: From enrollment until day 42]

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 · 23 centers
  • Draig Clinical Site — Bentonville
  • Draig Clinical Site — Little Rock
  • Draig Clinical Site — Oceanside
  • Draig Clinical Site — San Diego
  • Draig Clinical Site — Torrance
  • Draig Clinical Site — Miami
  • Draig Clinical Site — New Port Richey
  • Draig Clinical Site — Orlando
  • … and 15 more centers
United Kingdom · 6 centers
  • Draig Clinical Site — Chester
  • Draig Clinical Site — Eastbourne
  • Draig Clinical Site — Glasgow
  • Draig Clinical Site — London
  • Draig Clinical Site — Nottingham
  • Draig Clinical Site — Oxford
Bulgaria · 5 centers
  • Draig Clinical Site — Kazanlak
  • Draig Clinical Site — Pleven
  • Draig Clinical Site — Plovdiv
  • Draig Clinical Site — Sofia
  • Draig Clinical Site — Vratsa
Czechia · 3 centers
  • Draig Clinical Site — Ostrava
  • Draig Clinical Site — Prague
  • Draig Clinical Site — Říčany
Poland · 3 centers
  • Draig Clinical Site — Gdansk
  • Draig Clinical Site — Katowice
  • Draig Clinical Site — Poznan

Identifiers

NCT: NCT07300969 · DT-101/201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗