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NCT06701903 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Generalized Anxiety Disorder, sponsored by Intra-Cellular Therapies.

Recruiting
Registry status
Phase 2
Development phase
570
Enrollment target
20
Study locations

NCT06701903 is a Phase 2 study of Generalized Anxiety Disorder that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 570 participants, above the 203-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (181% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT06701903, a Phase 2 study of Generalized Anxiety Disorder, is actively recruiting participants, sponsored by Intra-Cellular Therapies.

RECRUITING
Registry status
Phase 2
Development phase
570 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Generalized Anxiety Disorder

Interventions

  • DRUG Placebo
  • DRUG ITI-1284 10 mg
  • DRUG ITI-1284 20 mg

Study Locations (20)

California

  • Clinical Site - Culver City
  • Clinical Site_2 - Encino
  • Clinical Site - Encino
  • Clinical Site - Los Angeles
  • Clinical Site - Oceanside
  • Clinical Site - Sherman Oaks
  • Clinical Site - Upland
  • Clinical Site - Walnut Creek

Florida

  • Clinical Site - Gainesville
  • Clinical Site - Miami
  • Cinical Site - Orlando
  • Clinical Site - Tampa
  • Clinical Site - Tampa

Arkansas

  • Clinical Site - Little Rock
  • Clinical Site - Rogers

Alabama

  • Clinical Site - Birmingham

Connecticut

  • Clinical Site - Farmington

Georgia

  • Clinical Site - Decatur

Illinois

  • Clinical Site - Chicago

Massachusetts

  • Clinical Site - Boston

Trial Details

FieldValue
Enrollment Target 570 participants
Start Date 2024-11-21
Est. Completion 2027-06
Phase Phase 2

Sponsor

Intra-Cellular Therapies

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06701903

The ClinicalTrials.gov registry entry for NCT06701903 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 570 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 203-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (181% higher). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Generalized Anxiety Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT06701903 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Arkansas.

Frequently Asked Questions

What is clinical trial NCT06701903 about?

NCT06701903 is a clinical study titled "Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder". 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 patie...

What is the current status of trial NCT06701903?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 570 participants. The study started on 2024-11-21. Estimated completion is 2027-06.

What conditions does trial NCT06701903 study?

This clinical trial studies the following conditions: Generalized Anxiety Disorder.

What interventions are being tested in trial NCT06701903?

The interventions under investigation include: Placebo (DRUG), ITI-1284 10 mg (DRUG), ITI-1284 20 mg (DRUG).

Who is sponsoring clinical trial NCT06701903?

This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06701903 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.