This study is testing a new medication called ITI-1284 to see if it can help people with Generalized Anxiety Disorder (GAD) when added to their current treatment. Researchers want to find out if ITI-1284 is effective, safe, and well-tolerated. You might be able to join if you are 18 or older, have moderate or severe GAD, and your current GAD treatment isn't working well enough. The study will compare two different doses of ITI-1284 (10 mg and 20 mg) to a placebo (an inactive pill). Success will be measured by changes in your anxiety symptoms after 6 weeks, using a tool called the Hamilton Anxiety Rating Scale (HAM-A). The study aims to enroll 705 participants, but its current recruitment status is unclear.

Study design

This is a multicenter, randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive ITI-1284 or a placebo, and neither you nor your doctor will know which you are receiving. The study plans to enroll 705 participants.

What's involved

You would participate in a screening period (up to 3 weeks), a 6-week treatment period where you take a daily sublingual tablet, and a 1-week safety follow-up visit.

Compensation

Not stated in the trial record.

Follow-up

Participants will have a 1-week safety follow-up period after the 6-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.