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Study identifier: NCT06701903 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Generalized Anxiety Disorder  ·  Sponsor: Intra-Cellular Therapies, Inc.

PhasePhase 2
Planned participants570
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

This description comes directly from the study's public registry record.

Talk to the study team

ITI Clinical Trials  ·  6464409333  ·  ITCIClinicalTrials@itci-inc.com

Always discuss trial participation with your own doctor first.

Locations (60)

Clinical SiteBirmingham, Alabama, United StatesRecruiting
Clinical SiteLittle Rock, Arkansas, United StatesRecruiting
Clinical SiteRogers, Arkansas, United StatesRecruiting
Clinical SiteCulver City, California, United StatesRecruiting
Clinical Site_2Encino, California, United StatesRecruiting
Clinical SiteEncino, California, United StatesRecruiting
Clinical SiteLos Angeles, California, United StatesRecruiting
Clinical SiteOceanside, California, United StatesRecruiting
Clinical SiteSherman Oaks, California, United StatesRecruiting
Clinical SiteUpland, California, United StatesActive Not Recruiting
Clinical SiteWalnut Creek, California, United StatesRecruiting
Clinical SiteFarmington, Connecticut, United StatesRecruiting

+ 48 more locations — full list on the registry record.

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