A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of a Fixed Dose of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder
This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \[mg/day\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).
• Male or female participants at least 18 years of age at the time of informed consent
• Primary diagnosis of GAD per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation
• Body Mass Index (BMI) 18-40 kilograms per square meter (kg/m\^2)
• Participant is willing and able to comply with study procedures and visit schedule
• Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests and able to comply with study procedures
• Willing and able to discontinue prohibited medications/therapies per protocol
• (i ) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception (ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions
• Willing and able to discontinue prohibited medications/therapies per protocol