A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment

November 2, 2026 updated by: Intra-Cellular Therapies, Inc.

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment and an Open-label Long-term Extension Treatment With JNJ-99245354 (ITI-1284)

The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

705

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Temecula, California, United States, 92591
        • Recruiting
        • Inland Psychiatric Medical Group Inc
    • Florida
      • Miami, Florida, United States, 33186
        • Recruiting
        • Nuovida Research Center
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Recruiting
        • Voltaire Clinical Research
    • New York
      • New York, New York, United States, 10017
        • Recruiting
        • Fieve Clinical Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at baseline
  • Medically stable on the basis of clinical laboratory tests performed at screening
  • History of inadequate response to at least 1 generalized anxiety disorder (GAD)-approved treatment taken at an adequate dose and duration as specified in the protocol for the treatment of ongoing GAD symptoms
  • Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the double blind (DB) treatment period of the trial
  • Body mass index (BMI) within the range 19-40 kilogram per meter squared (kg/m^2) (inclusive)

Exclusion criteria:

  • Within the participant's lifetime, has one of the following confirmed diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) text revision (TR) psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder
  • Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders (except simple phobias and social anxiety disorder); b. moderate or severe alcohol or substance use disorders (excluding nicotine); d. moderate or severe major depressive disorder; e. any other psychiatric condition (except for mild major depressive disorder [MDD]) that has been the main focus of treatment
  • Montgomery-asberg depression rating scale (MADRS) total score greater than (>)18 at screening or baseline
  • Lifetime history of inadequate response to >3 of the approved treatments for GAD at an adequate dose and for an adequate duration
  • The participant is taking more than 1 anti depressive therapy (ADT) or is taking ADT + buspirone at screening, regardless of indication, and is unable or unwilling to discontinue additional ADT (or buspirone) prior to baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JNJ-99245354: Dose 1

Participants will receive JNJ-99245354 dose 1 as an adjunctive therapy once daily for up to 6 weeks in the double blind (DB) period. Eligible participants can enter the open-label (OL) period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks.
Drug: JNJ-99245354

JNJ-99245354 will be administered sublingually.

Other Names:
  • ITI-1284
Experimental: JNJ-99245354: Dose 2

Participants will receive JNJ-99245354 dose 2 as an adjunctive therapy once daily for up to 6 weeks in the DB period. Eligible participants can enter the OL period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks.
Drug: JNJ-99245354

JNJ-99245354 will be administered sublingually.

Other Names:
  • ITI-1284
Placebo Comparator: Placebo

Participants will receive placebo as an adjunctive therapy once daily for up to 6 weeks in the DB period. Eligible participants can enter the OL period, to receive JNJ-99245354 dose 1 or dose 2 for up to 24 weeks.
Drug: JNJ-99245354

JNJ-99245354 will be administered sublingually.

Other Names:
  • ITI-1284
Drug: Placebo

Placebo will be administered sublingually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to End of Week 6 in Hamilton Anxiety Rating (HAM-A) Scale Total Score
Time Frame: Baseline, Week 6

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). Each item is 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 where higher score indicates greater severity in anxiety.
Baseline, Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to the End of Week 6 in Clinical Global Impression-Severity (CGI-S) Anxiety Score
Time Frame: Baseline, Week 6

The CGI-S scale is a standardized assessment tool that the clinician can use to rate the overall severity of illness. The CGI-S asks the clinician: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? CGI-S is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Here, higher score indicates higher symptom severity.
Baseline, Week 6
Change from Baseline to the End of Week 1 in HAM-A Total Score
Time Frame: Baseline, Week 1

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). Each item is 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 where higher score indicates greater severity in anxiety.
Baseline, Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Investigators

  • Study Director: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2026

Primary Completion (Estimated)

September 20, 2030

Study Completion (Estimated)

September 28, 2030

Study Registration Dates

First Submitted

September 28, 2026

First Submitted That Met QC Criteria

September 28, 2026

First Posted (Actual)

October 2, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99245354ANX3001
  • 2026-527319-40-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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