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



Status:Completed
Conditions:Anxiety, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 64
Updated:10/24/2018
Start Date:June 15, 2015
End Date:August 9, 2018

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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.

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).

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.

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
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