Recruiting
Phase 2

ITI-1284

Sponsor:

Intra-Cellular Therapies, Inc.

Code:

NCT06701903

Conditions

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ITI-1284 10 mg

ITI-1284 20 mg

Placebo

Study Details

Brief 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

Generalized Anxiety Disorder

Study ID

NCT06701903

Start date

Nov 21, 2024

Status verified date

Aug, 2026

Completion date

Jul 20, 2028

Anticipated

Primary completion date

Oct 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provide written informed consent before the initiation of any study specific procedures;
  • At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:

  • HAM-A Total score of ≥ 22;
  • HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;
  • CGI-S score of ≥ 4;
  • History of inadequate response (< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \[ATRQ\] for GAD) to at least 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 milligram \[mg\], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.

Exclusion Criteria:

  • Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:

  • Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
  • Bipolar Disorder;
  • MADRS total score > 18 at Screening or Baseline;
  • In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or

  • At Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit;
  • At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;
  • At Screening or Baseline MADRS Item 10 score ≥ 5; or
  • The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator;
  • Lifetime history of failure to respond to > 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks)

Study Design

Enrollment

570 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ITI-1284 10mg

ITI-1284 10 mg tablet, taken once daily, sublingual administration.

experimental: ITI-1284 20mg

ITI-1284 20 mg tablet, taken once daily, sublingual administration.

placebo comparator: Placebo

Matching placebo tablet, taken once daily, sublingual administration

Interventions

ITI-1284 10 mg

ITI-1284 10 mg tablet, taken once daily, sublingual administration.

ITI-1284 20 mg

ITI-1284 20 mg tablet, taken once daily, sublingual administration.

Placebo

Matching placebo tablet, taken once daily, sublingual administration

Primary outcome measure

  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Woodland International Research Group

Recruiting

Little Rock, Arkansas, United States, 72211

Woodland Research Northwest

Recruiting

Rogers, Arkansas, United States, 72758

Proscience Research Group

Recruiting

Culver City, California, United States, 90230

Leading Edge Research

Recruiting

Encino, California, United States, 91316

Wake Research PRI Encino

Recruiting

Encino, California, United States, 91316

CalNeuro Research

Recruiting

Los Angeles, California, United States, 90025

Excell Research Inc

Recruiting

Oceanside, California, United States, 92056

California Neuroscience Research

Recruiting

Sherman Oaks, California, United States, 91403

Sunwise Clinical Research

Recruiting

Walnut Creek, California, United States, 94596

University of Connecticut Health Center

Recruiting

Farmington, Connecticut, United States, 06032

Miami Dade Medical Research Institute

Recruiting

Miami, Florida, United States, 33176

University of South Florida

Recruiting

Tampa, Florida, United States, 33613

iResearch Atlanta LLC

Recruiting

Decatur, Georgia, United States, 30030

Precise Clinical Research, Inc.

Recruiting

Flowood, Mississippi, United States, 39232

SPRI Clinical Trials, LLC

Recruiting

Brooklyn, New York, United States, 11235

University of Buffalo

Recruiting

Buffalo, New York, United States, 14215

Richmond Behavioral Associates

Recruiting

Staten Island, New York, United States, 10314

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Sooner Clinical Research

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Suburban Research Associates

Recruiting

Media, Pennsylvania, United States, 19063

Relaro Medical Trials

Recruiting

Dallas, Texas, United States, 75243

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

More Information

Sponsor

Intra-Cellular Therapies, Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intra-Cellular Therapies, Inc. on 2026-08-31.