A Study of NTX-1472 in Social Anxiety Disorder

Change in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score

The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.

Time frame: Baseline to Week 8

Change in LSAS Fear/Anxiety and Avoidance subscale score

The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.

Time frame: Baseline to Week 8

Number and percentage of participants who are responders (≥50% improvement from Baseline [Day 1]) based on the LSAS total score

The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.

Time frame: Baseline to Week 8

Number and percentage of participants who are remitters based on an LSAS total score of <30

The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.

Time frame: Baseline to Week 8

Change in Hamilton Anxiety Rating Scale (HAM-A) total score

The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale that is designed to rate severity of anxiety. The total score ranges from 0 to 56. Higher scores indicate greater severity of anxiety.

Time frame: Baseline to Week 8

Clinical Global Impression - Severity (CGI-S) score

The Clinical Global Impression - Severity (CGI-S) score is rated on a 7-point scale, using a range of responses from 1 (normal, not at all ill) through to 7 (among the most extremely ill patients).

Time frame: Baseline to Week 8

Patient Global Impression - Severity (PGI-S) score

The Patient Global Impression - Severity (CGI-S) score is rated on a 7-point scale, using a range of responses from 1 (not present) through to 7 (extremely severe).

Time frame: Baseline to Week 8

Change in Depression Anxiety Stress Scale - 21 items (DASS-21, Stress subscale only)

The Depression Anxiety Stress Scale - 21 items (DASS-21), Stress subscale ranges from 0 to 21, with higher scores indicating greater stress severity.

Time frame: Baseline to Week 8

Change in University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score

The University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score ranges from 10 to 40, with higher scores indicating greater perceived loneliness.

Time frame: Baseline to Week 8

Change in Pittsburgh Sleep Quality Index (PSQI) global score

The Pittsburgh Sleep Quality Index (PSQI) global score ranges from 0 to 21, with higher scores indicating worse sleep quality.

Time frame: Baseline to Week 8

Change in State-Trait Anxiety Inventory (STAI) state

The State-Trait Anxiety Inventory (STAI) state score ranges from 20 to 80, with higher scores indicating greater anxiety in the moment.

Time frame: Baseline to Week 8