JNJ-99245354 for Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Intra-Cellular Therapies, Inc. Clinical Trial
Principal Investigator
Intra-Cellular Therapies, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with generalized anxiety disorder who still have symptoms despite trying at least one approved anxiety treatment. Participants must be medically stable, have a BMI between 19 and 40, and be able to stay as outpatients during the study.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- JNJ-99245354
Trial Overview
The study tests whether adding JNJ-99245354 (taken once daily) helps reduce anxiety more than a placebo when used alongside current treatments in people with GAD. Participants are randomly assigned to receive either the new drug or placebo.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
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Who Is Running the Clinical Trial?
Intra-Cellular Therapies, Inc.
Lead Sponsor
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