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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06480383

Public ClinicalTrials.gov record NCT06480383. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

Study identification

NCT ID
NCT06480383
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Enrollment
705 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 4, 2024
Primary completion
Mar 15, 2027
Completion
Mar 22, 2027
Last update posted
Aug 30, 2026

2024 – 2027

United States locations

U.S. sites
25
U.S. states
11
U.S. cities
20
Facility City State ZIP Site status
Behavioral Research Specialists LLC Glendale California 91206 Recruiting
Sun Valley Research Center Imperial California 92251 Recruiting
Synergy East Lemon Grove California 91945 Recruiting
Excell Research Inc Oceanside California 92056 Recruiting
NRC Research Institute Orange California 92868 Recruiting
Anderson Clinical Research Redlands California 92374 Recruiting
Premier Clinical Research Miami Florida 33122 Recruiting
Global Medical Institutes Miami Florida 33125 Recruiting
Miami Dade Medical Research Institute Miami Florida 33176 Recruiting
Sunshine Medical Solution Miami Florida 33186 Recruiting
South Florida Research Inc Miami Springs Florida 33166 Recruiting
K2 Medical Research Tampa Florida 33634 Recruiting
CenExeli Research LLC Atlanta Georgia 30030 Recruiting
Atlanta Center for Medical Research Atlanta Georgia 30331 Recruiting
Michigan Clinical Research Institute Ann Arbor Michigan 48105 Recruiting
Bio Behavioral Health Toms River New Jersey 08755 Recruiting
SPRI Clinical Trials, LLC Brooklyn New York 11235 Recruiting
Neuro Behavioral Clinical Research North Canton Ohio 44720 Recruiting
Sooner Clinical Research Oklahoma City Oklahoma 73120 Recruiting
Lehigh Center for Clinical Research LLC Allentown Pennsylvania 18103 Recruiting
Suburban Research Associates Media Pennsylvania 19063 Recruiting
Austin Clinical Trial Partners Austin Texas 78737 Recruiting
BioBehavioral Research of Austin PC Austin Texas 78759 Recruiting
Aims Trials LLC Plano Texas 75093 Recruiting
Northwest Clinical Research Center Bellevue Washington 98007 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06480383, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 30, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06480383 live on ClinicalTrials.gov.

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