Clinical TrialOpen-label extensionMajor Depressive Disorder (MDD)PlaceboPlaceboPlaceboRecruiting

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

This Phase III, randomised, double-blind, placebo-controlled trial (n=165) will evaluate the efficacy and safety of oral DT120 (LSD) in adults aged 18 to 74 years with major depressive disorder (MDD). Participants will be assigned to placebo, 50µg DT120 or 100µg DT120, with the main efficacy measure being change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. The study includes a 12-week single-dose treatment period in Part A, followed by a 40-week open-label extension in Part B. Adults must have a DSM-5-confirmed diagnosis of MDD, a current major depressive episode lasting 8 weeks to 24 months, a MADRS score of at least 26 and a Clinical Global Impression-Severity (CGI-S) score of at least 4 at screening and baseline. During the extension phase, participants may receive open-label retreatment with DT120 based on pre-specified safety and symptom severity criteria, and will be monitored for efficacy and safety.

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Target Enrollment
165 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

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

Study Arms & Interventions

Arm 1 - Placebo

inactive

A substance that is designed to have no therapeutic value

Interventions

  • Placebo
    • single dose• 1 doses total

Arm 2 - 50µg DT120

inactive

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Interventions

  • Placebo50
    • single dose• 1 doses total

    Unmatched intervention treated as placebo placeholder: DT120

Arm 3 - 100µg DT120

experimental

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Interventions

  • Placebo50
    • single dose• 1 doses total

    Unmatched intervention treated as placebo placeholder: DT120

Participants

Ages
18 – 74
Sexes
Male & Female

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 Details

Study Team

Sponsors & Collaborators

Locations

Lighthouse Psychiatry — Gilbert, Arizona, United States
Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
UCSF Department of Neurology — San Francisco, California, United States
Psychedelic Science Institute — Santa Monica, California, United States
Mountain View Clinical Research, Inc — Denver, Colorado, United States
Charter Research — Orlando, Florida, United States
CenExel Atlanta — Atlanta, Georgia, United States
CenExel Decatur — Decatur, Georgia, United States
CenExel Savannah — Savannah, Georgia, United States
Uptown Research Institute — Chicago, Illinois, United States
Adams Clinical Boston — Boston, Massachusetts, United States
Adams Clinical Harlem — New York, New York, United States
Cleveland Clinic — Cleveland, Ohio, United States
Adams Clinical Philadelphia — Philadelphia, Pennsylvania, United States
Coastal Carolina Research — North Charleston, South Carolina, United States
Cedar Clinical Research — Draper, Utah, United States
Inner Space Research — Orem, Utah, United States
VA Portland Healthcare System — Vancouver, Washington, United States