drugset / Trial / NCT06701903

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

NCT06701903 ↗

Phase 2 Recruiting 570 enrolled Intra-Cellular Therapies, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-11-21
Primary completion
2027-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ITI-1284 Unknown 10 mg Other
Subject ITI-1284 Unknown 20 mg Other