Recruiting
Phase 3

JNJ-99245354

Sponsor:

Intra-Cellular Therapies, Inc.

Code:

NCT07856420

Conditions

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-99245354

Placebo

Study Details

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

Study ID

NCT07856420

Start date

Sep 29, 2026

Status verified date

Nov, 2026

Completion date

Sep 28, 2030

Anticipated

Primary completion date

Sep 20, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

705 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

JNJ-99245354

JNJ-99245354 will be administered sublingually.

Placebo

Placebo will be administered sublingually.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Inland Psychiatric Medical Group Inc

Recruiting

Temecula, California, United States, 92591

Nuovida Research Center

Recruiting

Miami, Florida, United States, 33186

Voltaire Clinical Research

Recruiting

Springfield, Massachusetts, United States, 01103

Fieve Clinical Research Inc

Recruiting

New York, New York, United States, 10017

More Information

Sponsor

Intra-Cellular Therapies, Inc.

Last update posted

Nov 3, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Intra-Cellular Therapies, Inc. on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.