A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
Recruiting
Phase 3
Interventional Study
Major Depressive Disorder
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 74
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 165 (estimated)
- Sponsor
- Definium Therapeutics US, Inc. · Industry
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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
Trial Locations
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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 depres…
Contacts
Definium Therapeutics Clinical Trials Info Requests
1-332-282-0479
CONTACT