This study aims to test SEP-363856, a medicine for Generalized Anxiety Disorder (GAD), which is a condition causing excessive worry. The study will compare SEP-363856, taken in doses of 50-75 mg per day, to a placebo, which is a harmless pill with no real medicine. It's called a "double-blind" study because neither the participants nor the researchers know who gets the real medicine or the placebo, making the test fair.
The study lasts about 12 weeks, with an 8-week period where participants take either the medicine or placebo. Participants must be adults aged 18 to 65 who meet the criteria for GAD according to the DSM-5, a manual used by doctors to diagnose mental disorders. The medicine should be taken every night at bedtime.
Key Points:
- Participation lasts up to 12 weeks with regular visits.
- Participants must be between 18 and 65 years old with GAD.
- Potential risks include being ineligible if there's another major disorder or a significant risk of self-harm.
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