Assessing Long-Term Safety and Tolerability of ITI-1284 Alone or with Other Treatments in Adults with Generalized Anxiety Disorder

What This Trial Is About

Researchers are evaluating the long-term safety and tolerability of ITI-1284, given alone or with other medicines, in adults with generalized anxiety disorder GAD who have not responded well to previous treatments. GAD is a mental health condition marked by persistent, uncontrollable worry lasting six months or more. This Phase 3 trial involves participants with a history of inadequate response to GAD treatment. Participants include those rolling over from previous ITI-1284 studies and new participants. Roll-over participants continue their assigned ITI-1284 treatment or combination with GAD-approved treatment in this open-label study. New participants receive ITI-1284 alone or alongside an approved GAD treatment for up to 52 weeks. ITI-1284 is given sublingually during the study. Throughout the study, participants are regularly assessed for adverse events, anxiety severity using the Hamilton Anxiety Rating Scale, and clinical global impression scores up to Week 52. They provide informed consent, maintain outpatient status, and follow study procedures. Safety is monitored continuously, and the total participation can last up to one year.

A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)