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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Intra-Cellular Therapies, Inc. trials in the USA
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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