Randomized, Double-Blind Study of ITI-1284 Tablets as Treatment for Adults with Generalized Anxiety Disorder Who Did Not Fully Respond to Previous Therapies

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of ITI-1284 as a single treatment for adults with moderate to severe Generalized Anxiety Disorder GAD who have not adequately responded to previous treatments. This Phase 2 study is randomized, double-blind, and placebo-controlled, designed to compare different doses of ITI-1284 with a placebo. The study aims to address the needs of patients meeting DSM-5-TR criteria for GAD with a history of insufficient response to approved medications. The trial includes three periods a screening period lasting up to 2 weeks to assess eligibility and medication washout a 6-week double-blind treatment period where about 570 patients are randomly assigned to receive either ITI-1284 10 mg, ITI-1284 20 mg, or a matching placebo once daily via sublingual tablets and a 1-week safety follow-up after the last dose. Participants take their assigned tablets daily under blinded conditions to evaluate the treatment effects. Participants will undergo assessments using the Hamilton Anxiety Rating Scale HAM-A and the Clinical Global Impression Scale-Severity CGI-S at 6 weeks to measure anxiety severity and overall clinical status. Safety monitoring includes a follow-up visit about one week after treatment ends. The total participation time covers screening, treatment, and safety follow-up, with evaluations conducted at specified intervals to monitor response and tolerability.

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder