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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Urine samples, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects will attend the clinic for complete general health checks and to complete questionnaires."
  • "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."
  • "Participants will also have blood samples taken to allow analysis of how DT-101 is absorbed and used by the body."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether DT-101, used as an added treatment, can help adults with depression that has come back. Researchers will compare DT-101 with a placebo, which looks like the study drug but has no medicine. Participants will visit the clinic for health checks and answer questionnaires.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 75 years old. People of all gender identities may join.
  • Have been diagnosed with depression and have had at least one earlier episode besides the current one.
  • Can read, understand, and communicate in the language used at the study site.
  • Are willing to sign a form agreeing to join after learning about the study.

Who can't join

  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have a health condition or long-term disease that is not stable.
  • Have a major problem with the brain or nerves.
  • Have had a moderate or severe alcohol or drug use disorder in the 6 months before screening.
  • Have ever had a seizure.
  • The study doctor believes you cannot follow the study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (23)

AR

AZ

CA

FL

GA

IL

MA

NY

OH

PA

TX

WA