Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Generalized Anxiety Disorder, sponsored by Intra-Cellular Therapies.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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 is comprised 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)
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
| Field | Value |
|---|---|
| Enrollment Target | 570 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What NCT06701903 shows while recruiting
NCT06701903 is an interventional study that assigns participants to a tested intervention. The registered 570 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (181% 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.
NCT06701903 names 20 study sites across 8 states, led by 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.
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 NCT06701903's enrollment target sits among peer trials
570 4th of 48 higher than 45 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
-
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
RECRUITING · Phase 2
-
Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness
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
- NCT05000645 · 570 participants · NA
Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
- NCT06239844 · 570 participants · NA
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
- NCT07266831 · 570 participants · Phase 2
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
- NCT04410796 · 571 participants · Phase 2
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
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