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

Study 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.

Conditions

Generalized Anxiety Disorder

Interventions / Drugs

ITI-1284 10 mg ITI-1284 20 mg Placebo

View on ClinicalTrials.gov ↗

Sponsor

ITCI

Intra-Cellular Therapies

Neuroscience

F29/100

Study Details

Enrollment570 participants

Primary Completion—

Lead SponsorIntra-Cellular Therapies, Inc.

Data Retrieved2026-04-11 04:18:13.264680+00:00

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