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The primary goal of this Phase 2 clinical trial is to determine the effects of a novel V1a receptor antagonist (NTX-1472) in adults with Social Anxiety Disorder (SAD). The main questions this trial aims to answer are:
Researchers will compare the effects of NTX-1472 with matching placebo (a look-alike capsule that contains no drug).
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTX-1472 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTX-1472 | Drug | Daily (QD) x 8 weeks. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria
Key Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Newleos Therapeutics Clinical Trial Team | Contact | 978-780-5937 | clinicaltrials@newleos.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOAR Clinical Study Site | Recruiting | Encino | California | 91316 | United States |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Drug |
Daily (QD) x 8 weeks. |
|
| 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | Baseline to Week 8 |
| SOAR Clinical Study Site | Recruiting | Los Angeles | California | 90025 | United States |
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| SOAR Clinical Study Site | Recruiting | Oceanside | California | 92056 | United States |
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| SOAR Clinical Study Site | Recruiting | San Jose | California | 95124 | United States |
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| SOAR Clinical Study Site | Recruiting | Jacksonville | Florida | 32256 | United States |
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| SOAR Clinical Study Site | Recruiting | Tampa | Florida | 33615 | United States |
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| SOAR Clinical Study Site | Recruiting | Boston | Massachusetts | 02131 | United States |
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| SOAR Clinical Study Site | Active, not recruiting | Las Vegas | Nevada | 89119 | United States |
| SOAR Clinical Study Site | Recruiting | Brooklyn | New York | 11229 | United States |
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| SOAR Clinical Study Site | Recruiting | Memphis | Tennessee | 38119 | United States |
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| SOAR Clinical Study Site | Recruiting | Austin | Texas | 78737 | United States |
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