A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Change in MADRS Total Score From Baseline to Day 28
The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
Time frame: Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Relmada Site
Dothan, Alabama, United States
Relmada Site
Homewood, Alabama, United States
Relmada Site
Anaheim, California, United States
Relmada Site
Lafayette, California, United States
Relmada Site
Newport Beach, California, United States
Relmada Site
Orange, California, United States
Relmada Site
Redlands, California, United States
Relmada Site
Sherman Oaks, California, United States
Relmada Site
Farmington, Connecticut, United States
Relmada Site
Brandon, Florida, United States
...and 26 more locations