A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder

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).

Key Inclusion Criteria

1. Male or female participants at least 18 years of age at the time of informed consent
2. 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
3. Body Mass Index (BMI) 18-40 kilograms per square meter (kg/m^2)
4. Participant is willing and able to comply with study procedures and visit schedule
5. Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests and able to comply with study procedures
6. Willing and able to discontinue prohibited medications/therapies per protocol
7. (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
8. Willing and able to discontinue prohibited medications/therapies per protocol

Key Exclusion Criteria

1. 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
2. Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening
3. Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)
4. Significant suicide risk e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale [C-SSRS] or MADRS)
5. Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)
6. Prior exposure to restricted treatments
7. Pregnant or breastfeeding females
8. Participation in another investigational study within 180 days (or more than [>] 1 trial in last year)
9. Known history of human immunodeficiency virus seropositivity, hepatitis B or C