Adjunctive JNJ-99245354 for Generalized Anxiety Disorder (GAD)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial evaluates the effectiveness of once-daily JNJ-99245354 as an adjunctive therapy in adults with generalized anxiety disorder who have not responded adequately to prior GAD treatments. Participants are randomly assigned to receive either JNJ-99245354 or placebo in addition to their current therapy during a double-blind period. The study includes outpatient adults with stable health, a BMI between 19 and 40, and a history of insufficient response to at least one approved GAD treatment. Primary outcomes focus on changes in anxiety symptoms over the treatment period, with ongoing safety monitoring through clinical assessments and vital signs. Locations include clinics in California, Florida, and Massachusetts under the lead sponsor Intra-Cellular Therapies, Inc.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.