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

NCT07856420 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: 99245354ANX30012026-527319-40-00
• Study Type: interventional
• Target: 705
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to End of Week 6 in Hamilton Anxiety Rating (HAM-A) Scale Total Score

  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 Outcomes (2)

• Change from Baseline to the End of Week 6 in Clinical Global Impression-Severity (CGI-S) Anxiety Score

  Baseline, Week 6

• Change from Baseline to the End of Week 1 in HAM-A Total Score

  Baseline, Week 1

Study Arms (3)

JNJ-99245354: Dose 1

EXPERIMENTAL

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: Dose 2

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

JNJ-99245354 DRUG

JNJ-99245354 will be administered sublingually.

Also known as: ITI-1284

JNJ-99245354: Dose 1; JNJ-99245354: Dose 2; Placebo

Placebo DRUG

Placebo will be administered sublingually.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Intra-Cellular Therapies, Inc. Clinical Trial

  Intra-Cellular Therapies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 20, 2030
• Study Completion (Estimated): September 28, 2030
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share