Phase 2
N=149
A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder
Phobic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02432703 ↗Enrolled (actual)
149
Serious AEs
1.3%
Results posted
Sep 2021
Primary outcome: Primary: Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score — -22.4; -29.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-42165279 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score |
-22.4; -29.4 | — |
| SECONDARY Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales |
-10.7; -14.6; -11.7; -14.9 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score |
12.7; 18.6 | — |
| SECONDARY Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score |
23.6; 42.4 | — |
| SECONDARY Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score |
-3.0; -4.2 | — |
| SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score |
-1.9; -2.3 | — |
| SECONDARY Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score |
-0.9; -1.8 | — |
| SECONDARY Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score |
-0.4; -0.9 | — |
| SECONDARY Change From Baseline in HAM-D6 Total Score |
-0.7; -1.0 | — |
| SECONDARY Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score |
23.6; 44.1; 45.5; 35.6 | — |
| SECONDARY Percentage of Participants With >=50% Improvement From Baseline (Responders) in SIGH-A Total Score |
47.3; 45.6 | — |
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).
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 ( = 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
Data sourced from ClinicalTrials.gov (NCT02432703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.