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A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Sponsor: Intra-Cellular Therapies, Inc.
Summary
The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment and an Open-label Long-term Extension Treatment With JNJ-99245354 (ITI-1284)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
705
Start Date
2026-09-29
Completion Date
2030-09-28
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
JNJ-99245354
JNJ-99245354 will be administered sublingually.
Placebo
Placebo will be administered sublingually.
Locations (4)
Inland Psychiatric Medical Group Inc
Temecula, California, United States
Nuovida Research Center
Miami, Florida, United States
Voltaire Clinical Research
Springfield, Massachusetts, United States
Fieve Clinical Research Inc
New York, New York, United States