A Phase 3 test of DT120 for major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, double-blind, placebo-controlled study in adults with major depressive disorder. It includes a 12-week randomized period comparing DT120 to placebo, followed by a 40-week extension with the option for open-label DT120 treatment based on safety and symptom criteria. Approximately 165 participants aged 18 to 74 will be enrolled, all with DSM-5-confirmed MDD and moderate to severe baseline symptoms. The trial will evaluate safety and efficacy through standardized assessments and monitoring for potential retreatment during the extension phase.

Why it matters

Who can join: the full rules

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

Where it's running

• Preferred Research Partners, Inc.
  Little Rock, Arkansas, United States Recruiting
• ATP Clinical Research Orange County
  Orange, California, United States Recruiting
• Kadima Neuropsychiatry Institute
  San Diego, California, United States Recruiting
• Psychedelic Science Institute
  Santa Monica, California, United States Recruiting
• Mountain View Clinical Research, Inc
  Denver, Colorado, United States Recruiting
• Clinical Neuroscience Solutions, LLC (Jacksonville)
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Definium Therapeutics Clinical Trials Info Requests
• Email: clinicaltrials@definiumtx.com
• Phone: 1-332-282-0479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.