Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Generalized Anxiety Disorder, sponsored by Intra-Cellular Therapies.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The HAM-A Scale is a clinician-rated scale measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). It comprises of 14 items that are rated on a 5-point scale ranging from 0 = not present to 4 = very severe, disabling symptoms. The HAM-A total score ranges from 0 to 56 with a higher score indicating increased severity of anxiety symptoms.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 705 participants |
| Start Date | 2024-08-05 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What NCT06480383 shows while recruiting
NCT06480383 is an interventional study that assigns participants to a tested intervention. The registered 705 participants enrollment target is mid-sized for trials with a published cap, above the 200-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (253% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
Similar trials for Generalized Anxiety Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06480383's enrollment target sits among peer trials
705 2nd of 48 the highest of 48 other Generalized Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Anxiety Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Use of CBD in the Treatment of Anxiety
RECRUITING · Phase 2
-
Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness
RECRUITING · Phase 2
-
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
RECRUITING · Phase 2
-
A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD)
ACTIVE NOT RECRUITING · Phase 2
-
Combined Treatment for Generalized Anxiety Disorder (GAD)
COMPLETED · Phase 2
-
Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07067463 · 705 participants · Phase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
- NCT05796687 · 704 participants · NA
Evaluation of My Future Self, an New Teen Pregnancy Prevention Group Intervention for Youth in Non-traditional Settings
- NCT06350734 · 704 participants
Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
- NCT06027996 · 702 participants · NA
Melodi Matrix™ in Breast Reconstruction
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI