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

NCT ID: NCT02432703

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-11
• Study Completion Date: 2018-08-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-42165279

Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.

Group Type: EXPERIMENTAL

JNJ-42165279

Intervention Type: DRUG

Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.

Placebo

Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.

Interventions

JNJ-42165279

Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.

Intervention Type: DRUG

Placebo

Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must have a primary DSM-5 diagnosis of Social anxiety disorder (SAD) except those with performance only as a specifier. Participants with a diagnosis of comorbid Generalized Anxiety Disorder (GAD) or Major Depressive Disorder (MDD) may be included if the Investigator considers SAD to be the predominant diagnosis. Participants with current or lifetime history of Attention deficit hyperactivity disorder (ADHD) and specific phobia may be included as well
• Must have a Liebowitz Social Anxiety Scale score greater than or equal (>=) 70 at Screening and Baseline
• Participants with a current episode of MDD must have a HDRS17 total score less than or equal to (<=) 18
• Must have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2), inclusive, at screening
• Female participants must be either postmenopausal or surgically sterile

Exclusion Criteria

• Participants who have performance only SAD are excluded. Participants with other current significant psychiatric condition(s) (Axis 1 under DSM-IV), including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), autism spectrum disorders, post-traumatic stress disorder (PTSD) or schizophrenia are excluded. Participants with a diagnosis of comorbid GAD or MDD may be included
• Participants is currently receiving specific psychotherapy for SAD
• Has a history of more than two unsuccessful adequate pharmacological treatment trials for SAD, defined as lack of response to at least 10 weeks of treatment at adequate doses (e.g., paroxetine >= 40 milligram per day (mg/day) or its equivalent; or clonazepam >= 2.5 mg/day or its equivalent)
• Concurrent use of psychotropic medications
• has a history of or current thyroid disease, thyroid dysfunction and is currently untreated for it

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

La Jolla, California, United States

Hartford, Connecticut, United States

Orlando, Florida, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Natick, Massachusetts, United States

New York, New York, United States

Rochester, New York, United States

Staten Island, New York, United States

Allentown, Pennsylvania, United States

Reading, Pennsylvania, United States

Dallas, Texas, United States

Salt Lake City, Utah, United States

Adelaide, , Australia

Frankston, , Australia

Melbourne, , Australia

Perth, , Australia

Edmonton, Alberta, Canada

Hamilton, Ontario, Canada

Mississauga, Ontario, Canada

Toronto, Ontario, Canada

Countries

United States; Australia; Canada

References

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.

Reference Type: DERIVED

PMID: 33070154 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

42165279SAX2001

Identifier Type: OTHER

Identifier Source: secondary_id

2014-004258-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR106641

Identifier Type: -

Identifier Source: org_study_id