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Recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-09-29
Last updated
2026-11-03

Condition(s) studied

Generalized Anxiety Disorder

Investigational drug(s) / intervention(s)

JNJ-99245354 →Placebo

JNJ-99245354: JNJ-99245354 will be administered sublingually.

Placebo: Placebo will be administered sublingually.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (4)

FacilityCityRegionStatus
Inland Psychiatric Medical Group Inc Temecula California Recruiting
Nuovida Research Center Miami Florida Recruiting
Voltaire Clinical Research Springfield Massachusetts Recruiting
Fieve Clinical Research Inc New York New York Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07856420 on ClinicalTrials.gov ↗ ← All trials in the USA