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RecruitingPhase 3

A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral DT120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Ascend

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 74 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

Not stated in the study description — ask the study team about visits and procedures.

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 DT120 against a placebo (a treatment with no active drug) for major depressive disorder. It is for adults ages 18 to 74 who are having a major episode of depression. The study also has a later part where everyone knows which treatment they get.

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Major Depressive Disorder - Ascend

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

Eligibility

Who can join

  • Have major depressive disorder diagnosed using standard guidelines (DSM-5).
  • Be 18 to 74 years old.
  • Have a current episode of major depression lasting 8 weeks to 24 months.
  • Score at least 26 on the MADRS scale, which measures depression symptoms.
  • Score at least 4 on the CGI-S scale, which rates how severe the illness is.

Who can't join

  • Have certain other mental health disorders besides major depressive disorder.
  • Have ever had bipolar disorder (extreme mood shifts) or a psychotic disorder (trouble knowing what is real), or have a parent, sibling, or child with either disorder.
  • Currently have an alcohol or drug use disorder, except one involving nicotine or caffeine.
  • Have a serious illness that is not stable.

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

Official eligibility criteria

Inclusion Criteria: 1. Diagnosis of MDD per DSM-5 2. Male or female aged 18 to 74 3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration 4. MADRS Total Score ≥26 5. CGI-S Score ≥4 Exclusion Criteria: 1. Certain psychiatric disorders (other than major depressive disorder) 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine 4. Any clinically significant unstable illness

Study sites (30)

AR

CA

CO

FL

GA

IL

MA

MO

NV

NY

OH

PA

SC

TX

UT

VT

WA