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

NCT07592689

RecruitingPhase 3

Sponsor: Definium Therapeutics US, Inc.

Conditions: Major Depressive Disorder

Interventions: Placebo, DT120

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (30)
  • Little Rock, Arkansas, United States
  • Orange, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Savannah, Georgia, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • North Charleston, South Carolina, United States
  • Austin, Texas, United States
  • Draper, Utah, United States
  • Orem, Utah, United States
  • Bennington, Vermont, United States
  • Seattle, Washington, United States
  • Vancouver, Washington, United States