Generalized Anxiety Disorder study: JNJ-99245354
Official title 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
ClinicalTrials.gov ID: NCT07856420
What this study is testing
What is JNJ-99245354?
JNJ-99245354 is an investigational medicine, being studied as a potential treatment for generalized anxiety disorder.
Also referred to as ITI-1284.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and...
- 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...
- 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 likely can't join if
- Within the participant's lifetime, has one of the following confirmed diagnostic and statistical manual of mental disorders (5th edition) (DSM-5)...
- Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Temecula, California, United States
- Miami, Florida, United States
- Springfield, Massachusetts, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Temecula, California, United States; Miami, Florida, United States; Springfield, Massachusetts, United States; New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.