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Recruiting
NCT07592689
A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
Conditions: Major Depressive Disorder
Sex: All
Ages: 18 Years – 74 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 165
Sponsor: Definium Therapeutics US, Inc.
Location: Lighthouse Psychiatry Gilbert Arizona
Summary
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
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
Source: ClinicalTrials.gov (NCT07592689). StuddyBuddy aggregates publicly available trial information.
