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Phase 3Recruiting

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

Sponsored by Definium Therapeutics US, Inc.

About this study

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

The study will enroll approximately 165 participants aged 18 to 74 years, inclusive, with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of MDD, a minimum MADRS total score of at least 26 and a CGI-S score of at least 4 at Screening and Baseline without clinically relevant medical or psychiatric history. The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating DT120 versus placebo, followed by a 40-week Extension Phase (EP) with opportunity for open-label treatment during which participants will be monitored and evaluated for potential retreatment with DT120 based on pre-specified safety and symptom severity criteria.

Where this study is enrolling (30)

Show all 30 locations
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.