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

Phase 2 Completed 150 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2015-06-11
Primary completion: 2018-08-09
Completion: 2018-08-09

Outcome

Missed primary endpoint

paper LSAS total score at week 12 was numerically greater for JNJ-42165279: -29.4 (27.47) compared to PBO: -22.4 (23.57) but not significant. PMID 33070154 ↗

Publications

Schmidt ME, Liebowitz MR, Stein MB, Grunfeld J, Van Hove I, Simmons WK, Van Der Ark P, Palmer JA, Saad ZS, Pemberton DJ, Van Nueten L, Drevets WC. The effects of inhibition of fatty acid amide hydrolase (FAAH) by JNJ-42165279 in social anxiety disorder: a double-blind, randomized, placebo-controlled proof-of-concept study. Neuropsychopharmacology. 2021 Apr;46(5):1004-1010. doi: 10.1038/s41386-020-00888-1. Epub 2020 Oct 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-42165279	Small molecule	25 mg	Oral