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

NCT ID
NCT07856420
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Intra-Cellular Therapies, Inc.
Conditions
Generalized Anxiety Disorder

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: 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)

Enrollment: 705 participants (Estimated).

What is being studied

  • Drug: JNJ-99245354
  • Drug: Placebo

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

No study locations are listed in the registry data.

Study details

Start date
September 30, 2026
Primary completion date
September 20, 2030
Completion date
September 28, 2030
First posted
October 2, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07856420
Registry last updated
October 2, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07856420 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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