Summary

for people ages 18-64 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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).

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.

Details

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.

Keywords

Phobic Disorders Social Anxiety Disorder JNJ-42165279 Disease Anxiety Disorders Phobia, Social

Eligibility

You can join if…

Open to people ages 18-64

  • 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/m2), inclusive, at screening

  • Female participants must be either postmenopausal or surgically sterile

You CAN'T join 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

Locations

  • University of California at San Diego in progress, not accepting new patients
    La Jolla California 92093 United States
  • PRA Health Sciences in progress, not accepting new patients
    Salt Lake City Utah 84106 United States
  • Future Search Trials of Dallas in progress, not accepting new patients
    Dallas Texas 75231 United States
  • Chokka Center for Integrative Health accepting new patients
    Edmonton Alberta T6L 6W6 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT02432703
Phase
Phase 2
Study Type
Interventional
Last Updated
May 30, 2018