A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder
Condition: Phobic Disorders
MeSH terms: Anxiety Disorders; Phobia, Social; Phobic Disorders
Intervention: JNJ-42165279; Placebo
Intervention description: Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.; Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.
Intervention MeSH terms: JNJ-42165279
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Social Anxiety Disorder; JNJ-42165279

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 (<=) 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