This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.
Male or female participants at least 18 years of age at the time of informed consent
Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
Participant is willing and able to comply with study procedures and visit schedule
Diagnosis other than GAD that is the primary focus of treatment
Clinically significant psychiatric or medical condition that may interfere with study participation
Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes
Clinically significant abnormal laboratory values or ECG findings
Single group
SEP-363856
DrugOral tablet
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation
Change From Baseline 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 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 participants), where a higher score is associated with greater illness severity. A decrease in value indicates improvement.
Percentage of Participants With Any Change in Laboratory Tests Values From Baseline
Percentage of Participants With Any Change in Potentially Clinically Relevant Vital Signs From Baseline
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
Percentage of Participants With Any Change From Baseline in 12-Lead Electrocardiogram (ECG)
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