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NCT06480383 · ClinicalTrials.gov registry record · Phase 2

Study of ITI-1284 as an Adjunctive 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
705
Enrollment target
20
Study locations

NCT06480383 is a Phase 2 study of Generalized Anxiety Disorder that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 705 participants, above the 200-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (253% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT06480383, a Phase 2 study of Generalized Anxiety Disorder, is actively recruiting participants, sponsored by Intra-Cellular Therapies.

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

Study Summary

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.

Conditions Studied

Generalized Anxiety Disorder

Interventions

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

Study Locations (20)

Florida

  • Clinical Site - Gainesville
  • Clinical Site - Lauderhill
  • Clinical Site - Maitland
  • Clinical Site - Miami
  • Clinical Site - Miami
  • Clinical Site - Miami
  • Clinical Site - Miami Springs
  • Clinical Site - Orlando
  • Clinical Site - Tampa

California

  • Clinical Site - Encino
  • Clinical Site - Glendale
  • Clinical Site - Imperial
  • Clinical Site - Lemon Grove
  • Clinical Site - Oceanside
  • Clinical Site - Orange
  • Clinical Site - Redlands
  • Clinical Site - San Diego

Arizona

  • Clinical Site - Chandler

Connecticut

  • Clinical Site - Farmington

Georgia

  • Clinical Site - Atlanta

Trial Details

FieldValue
Enrollment Target 705 participants
Start Date 2024-08-05
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 NCT06480383

The ClinicalTrials.gov registry entry for NCT06480383 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 705 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 200-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (253% 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.

NCT06480383 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT06480383 about?

NCT06480383 is a clinical study titled "Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder". 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...

What is the current status of trial NCT06480383?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 705 participants. The study started on 2024-08-05. Estimated completion is 2027-06.

What conditions does trial NCT06480383 study?

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

What interventions are being tested in trial NCT06480383?

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

Who is sponsoring clinical trial NCT06480383?

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

Where is trial NCT06480383 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. 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.