The purpose of this study is to better understand the efficacy and safety of flexible doses of SEP-363856 (50 – 75 mg/day) compared with placebo in adults with Generalized Anxiety Disorder (GAD).

You may qualify for this study if you meet the following criteria.

Inclusion Criteria:

• Ages 18-65
• Have a diagnosis or symptoms of Generalized Anxiety Disorder (GAD)
• No psychiatric diagnosis other than anxiety (e.g., depression, schizophrenia, bipolar disorder, obsessive compulsive disorder)
• Not taking anticonvulsant or mood stabilizers
• Have never undergone electroconvulsive therapy (ECT)
• If applicable, on stable doses of medication
• No suicidal ideation
• If female, not pregnant, breastfeeding, or planning to become pregnant
• Have had a previous allergic reaction to a medication
• Have not participated in a previous clinical trial for GAD

If you take part, you will be in the study for up to 12 weeks. Participants will receive either the ingestible medication or a placebo (together referred to as “study medication”). A placebo looks like the ingestible medication but contains no active ingredients.

The study medication tablets are taken by mouth at the same time in the evening.

Once enrolled, this study involves:

• Weekly visits to the study center almost every week for 9 weeks.
• During these visits, participants will provide information about their condition, complete questionnaires with the study doctor, provide blood and urine samples, and receive physical examinations to check their health.
• Each visit will take between 1 and 5 hours. 

Participants will be compensated $150 per visit for their time and participation.

There is no cost for you to participate in our research study.