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NOT YET 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

2026-09-30

Completion Date

2030-09-28

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DRUG

JNJ-99245354

JNJ-99245354 will be administered sublingually.

DRUG

Placebo

Placebo will be administered sublingually.