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

ClinicalTrials.gov ID: NCT06701903

Public ClinicalTrials.gov record NCT06701903. 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 4, 2026, 4:28 AM 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 Monotherapy Treatment in Patients With Generalized Anxiety Disorder Who Have Had 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 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.

Study identification

NCT ID: NCT06701903
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Intra-Cellular Therapies, Inc.; Industry
Enrollment: 570 participants

Conditions and interventions

Conditions

Generalized Anxiety Disorder

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
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: Nov 20, 2024
Primary completion: Oct 13, 2027
Completion: Jul 19, 2028
Last update posted: Aug 30, 2026

2024 – 2028

United States locations

U.S. sites: 25
U.S. states: 13
U.S. cities: 24

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35294	Recruiting
Woodland International Research Group	Little Rock	Arkansas	72211	Recruiting
Woodland Research Northwest	Rogers	Arkansas	72758	Recruiting
Proscience Research Group	Culver City	California	90230	Recruiting
Leading Edge Research	Encino	California	91316	Recruiting
Wake Research PRI Encino	Encino	California	91316	Recruiting
CalNeuro Research	Los Angeles	California	90025	Recruiting
Excell Research Inc	Oceanside	California	92056	Recruiting
California Neuroscience Research	Sherman Oaks	California	91403	Recruiting
Pacific Clinical Research Medical Group	Upland	California	91786	Completed
Sunwise Clinical Research	Walnut Creek	California	94596	Recruiting
University of Connecticut Health Center	Farmington	Connecticut	06032	Recruiting
Sarkis Clinical Trials	Gainesville	Florida	32607	Completed
Miami Dade Medical Research Institute	Miami	Florida	33176	Recruiting
University of South Florida	Tampa	Florida	33613	Recruiting
iResearch Atlanta LLC	Decatur	Georgia	30030	Recruiting
Precise Clinical Research, Inc.	Flowood	Mississippi	39232	Recruiting
SPRI Clinical Trials, LLC	Brooklyn	New York	11235	Recruiting
University of Buffalo	Buffalo	New York	14215	Recruiting
Richmond Behavioral Associates	Staten Island	New York	10314	Recruiting
The Ohio State University	Columbus	Ohio	43210	Recruiting
Sooner Clinical Research	Oklahoma City	Oklahoma	73116	Recruiting
Suburban Research Associates	Media	Pennsylvania	19063	Recruiting
Relaro Medical Trials	Dallas	Texas	75243	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 26 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06701903, 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 4, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06701903 live on ClinicalTrials.gov.

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