Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-11-20; most recent amendment 2026-01-07.
Trial Details
NCT Number NCT06701903
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Generalized Anxiety Disorder
Enrollment 570 participants
Start Date 2024-11-21
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-09