Evaluating JNJ-99245354 as an Additional Treatment for Generalized Anxiety Disorder in Patients with Inadequate Response to Prior Therapies Including a Long-term Extension Phase

What This Trial Is About

Researchers are studying the use of JNJ-99245354, a drug given once daily, to see if it helps reduce anxiety better than a placebo when added to existing treatment for people with generalized anxiety disorder GAD. GAD is a mental health condition characterized by uncontrollable and excessive worry about everyday events over a long period. This trial is a phase 3 study focused on treatment effectiveness in patients who have not responded adequately to prior GAD therapies. Participants will be randomly assigned to one of three groups during a double-blind period lasting up to 6 weeks one group receives JNJ-99245354 at dose 1, another at dose 2, and the last group receives a placebo. Following this, eligible participants may enter an open-label phase for up to 24 weeks to receive either dose 1 or dose 2 of JNJ-99245354. Both the study drug and placebo are administered sublingually under the tongue. Throughout the study, participants will be regularly evaluated using anxiety rating scales, including the Hamilton Anxiety Rating Scale HAM-A and the Clinical Global Impression-Severity CGI-S Anxiety Score. Researchers will monitor participants medical stability through physical exams, lab tests, vital signs, and ECGs. The main outcome is the change in anxiety symptoms from baseline to the end of week 6. Safety, tolerability, and longer-term effects will also be assessed during the open-label extension. The total participation may last up to about 30 weeks or more depending on eligibility for the extension phase.

A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment