Clinical Trial

Study of ITI-1284 as an Adjunctive 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 evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-06-24; most recent amendment 2026-01-07.
Trial Details
NCT Number NCT06480383
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Generalized Anxiety Disorder
Enrollment 705 participants
Start Date 2024-08-05
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-09