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

Active Not 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 - Emerge

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 (22)

Little Rock, Arkansas, United States
La Jolla, California, United States
Santa Monica, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Watertown, Massachusetts, United States
Columbia, Missouri, United States
Berlin, New Jersey, United States
New York, New York, United States
New York, New York, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Murray, Utah, United States
Bennington, Vermont, United States