A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
327
Change in MADRS Total Score From Baseline to Week 6
The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. 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: 6 weeks
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Clinical Research Site
Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Bellflower, California, United States
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Beverly Hills, California, United States
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Garden Grove, California, United States
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Oakland, California, United States
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Oceanside, California, United States
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Panorama City, California, United States
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Redlands, California, United States
...and 33 more locations