A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of Fixed Doses 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, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.
• Male or female participants at least 18 years of age at the time of informed consent
• Primary diagnosis of Generalized Anxiety Disorder (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) between 18 and 40 kilograms per square meter (kg/m\^2) (inclusive)
• 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
• 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
• Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period.