A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorDefinium Therapeutics US, Inc.
About this trial
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
Qualifiers
Diagnosis of MDD per DSM-5
Male or female aged 18 to 74
Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration
MADRS Total Score ≥26
Disqualifiers
Certain psychiatric disorders (other than major depressive disorder)
First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine
Any clinically significant unstable illness
Trial design
Treatments tested in this trial
- Placebo
- DT120
Treatment groups
165 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov