drugset / Trial / NCT06480383

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

NCT06480383 ↗

Phase 2 Recruiting 705 enrolled Intra-Cellular Therapies, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-08-05
Primary completion
2027-06
Completion
2027-06

Drugs

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