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
Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
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.
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 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 3. Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2) (inclusive) 4. Participant is willing and able to comply with study procedures and visit schedule 5. Medically stable as determined by medical history, physical exa…
Interventions
- DrugSEP-363856
Oral tablet
- OtherPlacebo
Oral tablet
Locations (3)
- Clinical Neuroscience Solutions, LLCJacksonville, Florida
- Manhattan Behavioral Medicine PLLCNew York, New York
- FutureSearch Trials of DallasDallas, Texas