NCT02432703

A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder

A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-42165279 in Subjects With Social Anxiety Disorder.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of treatment in participants with Social Anxiety Disorder (SAD).

Detailed description

This is a Phase 2a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participants know about the study intervention), placebo-controlled, parallel-group, multi-center study of JNJ-42165279 in participants with social anxiety disorder. Participants will receive 25 milligram (mg) JNJ-42165279 or matching placebo orally once-daily from Day 1 up to 12 weeks. Participants will primarily be assessed for the change from baseline in Liebowitz Social Anxiety Scale (LSAS) at Week 12. Safety will be monitored throughout the study.

Conditions

• Phobic Disorders

Interventions

Type	Name	Description
DRUG	JNJ-42165279	Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.
DRUG	Placebo	Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.

Timeline

• Start date: 2015-06-11
• Primary completion: 2018-08-09
• Completion: 2018-08-09
• First posted: 2015-05-04
• Last updated: 2025-04-29
• Results posted: 2021-09-02

Locations

21 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study