A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Definium Therapeutics US, Inc.
- Study ID
- NCT07592689
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 74 Years
- Healthy Volunteers
- Not accepted
Interventions
- Placebo — OTHERA substance that is designed to have no therapeutic value
- DT120 — DRUGA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Study Details
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
Key Dates
- Start date
- May 10, 2026
- Status verified
- May 2026
- Primary completion
- Sep 30, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 165 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Arm 1 - PlaceboA substance that is designed to have no therapeutic value
- Sham Comparator: Arm 2 - 50µg DT120A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
- Experimental: Arm 3 - 100µg DT120A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Primary Outcome Measure
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 [ Time Frame: Baseline to Week 6 ]
Central Contacts
- Definium Therapeutics Clinical Trials Info Requests1-332-282-0479
Locations (27)
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