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

NCT02432703 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR10664142165279SAX20012014-004258-32
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 21

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).

Conditions

Phobic Disorders

Keywords

Social Anxiety Disorder; JNJ-42165279

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score

  The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear/anxiety and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of social anxiety disorder (SAD).

  Baseline and Week 12

Secondary Outcomes (10)

• Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales

  Baseline and Week 12

• Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score

  Week 12

• Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score

  Week 12

• Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score

  Baseline and Week 12

• Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score

  Baseline and Week 12

Study Arms (2)

JNJ-42165279

EXPERIMENTAL

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

Drug: JNJ-42165279

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JNJ-42165279 DRUG

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

JNJ-42165279

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (21)

Unknown Facility

La Jolla, California, United States

Location

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Hartford, Connecticut, United States

Location

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Orlando, Florida, United States

Location

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Chicago, Illinois, United States

Location

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Boston, Massachusetts, United States

Location

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Natick, Massachusetts, United States

Location

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New York, New York, United States

Location

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Rochester, New York, United States

Location

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Staten Island, New York, United States

Location

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Allentown, Pennsylvania, United States

Location

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Reading, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

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Salt Lake City, Utah, United States

Location

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Adelaide, Australia

Location

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Frankston, Australia

Location

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Melbourne, Australia

Location

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Perth, Australia

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

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Hamilton, Ontario, Canada

Location

Unknown Facility

Mississauga, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 33070154 DERIVED

MeSH Terms

Conditions

Phobic Disorders; Phobia, Social

Interventions

JNJ-42165279

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Limitations and Caveats

The US food and drug administration placed a clinical hold on studies being conducted with fatty acid amide hydrolase (FAAH) inhibitor. When determined that serious adverse events were not related to FAAH inhibition, Janssen resumed this study in December 2016. At time of study suspension, an unblinded safety analysis was performed, and hence sample size was increased to replace participants who withdrew due to study suspension. Planned analyses were performed at time of final database lock.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 4, 2015
• Study Start: June 11, 2015
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: April 29, 2025
• Results First Posted: September 2, 2021

Record last verified: 2025-04

Locations

AU (4); US (13); CA (4)