Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02432703 | A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder | PHASE2 | COMPLETED | 150 | — | — | Jun 11, 2015 | Aug 9, 2018 | Apr 29, 2025 | 21 | United States, Australia +1 |
The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear/anxiety and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of social anxiety disorder (SAD).
| Arm | Type | Description |
|---|---|---|
| JNJ-42165279 | EXPERIMENTAL | Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks. |
| Name | Type | Description |
|---|---|---|
| JNJ-42165279 | DRUG | Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks. |
| Placebo | DRUG | Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks. |
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...