A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
Purpose
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
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Arm 1 - Placebo |
A substance that is designed to have no therapeutic value |
|
|
Sham Comparator Arm 2 - 50µg DT120 |
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
|
|
Experimental Arm 3 - 100µg DT120 |
A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
|
Recruiting Locations
Little Rock, Arkansas 72211
Denver, Colorado 80209
Chicago, Illinois 60640
Boston, Massachusetts 02116
New York, New York 10029
Philadelphia, Pennsylvania 19104
North Charleston, South Carolina 29405
Draper, Utah 84020
Orem, Utah 84058
More Details
- Status
- Recruiting
- Sponsor
- Definium Therapeutics US, Inc.
Study Contact
Definium Therapeutics Clinical Trials Info Requests1-332-282-0479
clinicaltrials@definiumtx.com
Detailed Description
The study will enroll approximately 165 participants aged 18 to 74 years, inclusive, with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of MDD, a minimum MADRS total score of at least 26 and a CGI-S score of at least 4 at Screening and Baseline without clinically relevant medical or psychiatric history. The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating DT120 versus placebo, followed by a 40-week Extension Phase (EP) with opportunity for open-label treatment during which participants will be monitored and evaluated for potential retreatment with DT120 based on pre-specified safety and symptom severity criteria.