Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment
Intra-Cellular Therapies, Inc.
570 participants
Nov 21, 2024
INTERVENTIONAL
Conditions
Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
ITI-1284 10 mg tablet, taken once daily, sublingual administration.
ITI-1284 20 mg tablet, taken once daily, sublingual administration.
Matching placebo tablet, taken once daily, sublingual administration
Locations(60)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06701903