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

NCT06701903

This study is recruiting at 23 US sites in 13 states, according to its ClinicalTrials.gov record last updated .

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Generalized Anxiety Disorder

Eligibility basics and study details

Study type
Interventional
Phase
Phase 2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Intra-Cellular Therapies, Inc.
Last updated on ClinicalTrials.gov
September 25, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Alabama · 1

  • University of Alabama at Birmingham · Birmingham, AL

Arkansas · 2

  • Woodland International Research Group · Little Rock, AR
  • Woodland Research Northwest · Rogers, AR

California · 7

  • Proscience Research Group · Culver City, CA
  • Leading Edge Research · Encino, CA
  • Wake Research PRI Encino · Encino, CA
  • CalNeuro Research · Los Angeles, CA
  • Excell Research Inc · Oceanside, CA
  • California Neuroscience Research · Sherman Oaks, CA
  • Sunwise Clinical Research · Walnut Creek, CA

Connecticut · 1

  • University of Connecticut Health Center · Farmington, CT

Florida · 2

  • Miami Dade Medical Research Institute · Miami, FL
  • University of South Florida · Tampa, FL

Georgia · 1

  • iResearch Atlanta LLC · Decatur, GA

Mississippi · 1

  • Precise Clinical Research, Inc. · Flowood, MS

New York · 3

  • SPRI Clinical Trials, LLC · Brooklyn, NY
  • University of Buffalo · Buffalo, NY
  • Richmond Behavioral Associates · Staten Island, NY

Ohio · 1

  • The Ohio State University · Columbus, OH

Oklahoma · 1

  • Sooner Clinical Research · Oklahoma City, OK

Pennsylvania · 1

  • Suburban Research Associates · Media, PA

Texas · 1

  • Relaro Medical Trials · Dallas, TX

Washington · 1

  • Northwest Clinical Research Center · Bellevue, WA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.