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
Randomised controlled trialHumansWith JNJ-42165279 (a FAAH inhibitor that raises endogenous PEA, anandamide and OEA, tested alone)
This study tested palmitoylethanolamide together with JNJ-42165279 (a FAAH inhibitor that raises endogenous PEA, anandamide and OEA, tested alone). Its results cannot be assigned to palmitoylethanolamide alone. More combination studies.
- Design
- Randomised controlled trial
- Subjects
- 149 adults with social anxiety disorder, mean baseline LSAS 102.6 (SD 16.84)
- Dose used in the study
- JNJ-42165279 25 mg daily by mouth, or placebo
- Duration
- 12 weeks
- What was measured
- Change in Liebowitz Social Anxiety Scale (LSAS) total score (primary); HAM-A, HDRS17 and CGI-I; plasma anandamide, PEA, OEA and drug levels; safety and tolerability
What the authors reported
This trial found:
- Mean LSAS change at week 12 was -29.4 (SD 27.47) with the drug versus -22.4 (23.57) with placebo, not statistically significant.
- Responders with 30% or more LSAS improvement were 42.4% versus 23.6% (p=0.04).
- CGI-I much or very much improved in 44.1% versus 23.6% (p=0.02).
- The drug was well tolerated.
- Trough levels appeared too low to fully inhibit FAAH.
Limits of this study
The primary endpoint was not met; the positive results are secondary responder analyses. PEA was measured as a plasma marker, not given. Most authors' affiliations suggest the sponsor is Janssen, but conflicts are not stated in the abstract.
Source
PubMed 33070154 · doi:10.1038/s41386-020-00888-1
Entry checked against the abstract on PubMed on 2026-09-22. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.