Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT06480383 · View on ClinicalTrials.gov ↗

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.

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

54 total trials

Interested in This Trial?

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 705 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06480383 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06480383?

This trial is sponsored by Intra-Cellular Therapies, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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