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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Phobic Disorders

Treatments: Drug: Placebo; Drug: JNJ-42165279

Study type: Interventional

Funder types: Industry

Identifiers

NCT02432703

42165279SAX2001 (Other Identifier)

CR106641

2014-004258-32 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

JNJ-42165279

Experimental group

Description:

Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.

Treatment:

Drug: JNJ-42165279

Placebo

Placebo Comparator group

Description:

Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.

Treatment:

Drug: Placebo