Clinical trial NCT02432703: A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Phobic Disorders
Keywords: Social Anxiety Disorder
JNJ-42165279
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales
timeFrame: Baseline and Week 12
measure: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score
timeFrame: Week 12
measure: Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score
timeFrame: Week 12
measure: Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in HAM-D6 Total Score
timeFrame: Baseline and Week 12
measure: Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score
timeFrame: Week 12
measure: Percentage of Participants With >=50% Improvement From Baseline (Responders) in SIGH-A Total Score
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Hartford
country: United States
state: Connecticut
city: Orlando
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Natick
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Allentown
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Adelaide
country: Australia
city: Frankston
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Edmonton
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.