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 groupsLocations
27Arizona
Lighthouse Psychiatry85234, Gilbert United States
Arkansas
Preferred Research Partners, Inc.72211, Little Rock United States
California
Kadima Neuropsychiatry Institute92037, San Diego United States
UCSF Department of Neurology94158, San Francisco United States
Sponsors and collaborators
Definium Therapeutics US, Inc.
Lead sponsor
Source ClinicalTrials.gov