This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD). The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
337
capsule
capsule
capsule
Yuma CNS Research
Yuma, Arizona, United States
SanRo Clinical Research Group LLC
Bryant, Arkansas, United States
Behavioral Research Specialists-California-Irvine
Glendale, California, United States
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
Lafayette, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, United States
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Time frame: Baseline, Week 6
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Synergy Research Centers - SRC - ERG - PPDS
Lemon Grove, California, United States
ATP Clinical Research
Orange, California, United States
NRC Research Institute - Orange - PPDS
Orange, California, United States
Prospective Research Innovations
Rancho Cucamonga, California, United States
Anderson Clinical Research - ClinEdge - PPDS
Redlands, California, United States
...and 52 more locations