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/m²)
Participant is willing and able to comply with study procedures and visit schedule
Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening
Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
Significant suicide risk e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale [C-SSRS] or MADRS)
Parallel
SEP-363856
DrugOral tablet
Placebo
DrugOral tablet
Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score
The HAM-A is a clinician-administered rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is scored on a 5-point Likert-type scale ranging from 0 (absent) to 4 (very severe). The total score ranges from 0 to 56, with higher scores indicating greater severity.
Change From Baseline at Week 8 in Clinical Global Impression-Severity (CGI-S) Score
The CGI-S is a clinician-rated assessment of the participant's current illness state on a 7-point Likert-type scale (1=normal, not at all ill; 7=among the most extremely ill patients), where a higher score is associated with greater illness severity. A decrease in value indicates improvement.
Proportion of Participants Achieving HAM-A Response Criterion at Week 8 (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline in HAM-A Total Score)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Discontinuation
Percentage of Participants With any Change in Laboratory Tests Values From Baseline
Percentage of Participants With Any Change From Baseline in Vital Signs
Vital signs including blood pressure, heart rate, and body temperature will be recorded.
Percentage of Participants With Any Change From Baseline in Weight, Body Mass Index (BMI) and Waist Circumference
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