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
Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugSEP-363856
Oral tablet
- DrugPlacebo
Oral tablet
Locations (2)
- Lumina Clinical Research CenterCherry Hill, New Jersey
- Basil ClinicalJamaica, New York