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RECRUITING
NCT07856420
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

JNJ-99245354

JNJ-99245354 will be administered sublingually.

DRUG

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