RecruitingPhase 3NCT07807865

A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)

An Open-label, Multicenter Trial to Assess the Long-term Safety and Tolerability of ITI 1284 as Either Adjunctive or Monotherapy Treatment in Patients With Generalized Anxiety Disorder (GAD) With a History of Inadequate Response to GAD Treatment


Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

900 participants

Start Date

Sep 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ITI-1284 for people with generalized anxiety disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGITI-1284

ITI-1284 will be administered sublingually.


Locations(1)

CalNeuro Research

Los Angeles, California, United States

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NCT07807865


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