A Study of NTX-1472 in Social Anxiety Disorder

Официальное название

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of NTX-1472, a V1a Receptor Antagonist, in Adults With Social Anxiety Disorder

Обзор

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: * Is NTX-1472 safe and well tolerated in adults with SAD? * How effectively does NTX-1472 treat adults with SAD? Researchers will compare the effects of NTX-1472 with matching placebo (a look-alike capsule that contains no drug). Participants will: * Take NTX-1472 or matching placebo every day for 8 weeks * Visit the clinic 6 times over the course of 14 weeks for checkups and tests

Вмешательства

• Препарат NTX-1472
  Daily (QD) x 8 weeks.
• Препарат Placebo
  Daily (QD) x 8 weeks.

Первичные конечные точки

• Incidence and severity of treatment-emergent adverse events (TEAEs) [Срок оценки: Baseline to Week 8]

Вторичные конечные точки (11)

• Change in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score [Срок оценки: Baseline to Week 8]
• Change in LSAS Fear/Anxiety and Avoidance subscale score [Срок оценки: Baseline to Week 8]
• Number and percentage of participants who are responders (≥50% improvement from Baseline [Day 1]) based on the LSAS total score [Срок оценки: Baseline to Week 8]
• Number and percentage of participants who are remitters based on an LSAS total score of <30 [Срок оценки: Baseline to Week 8]
• Change in Hamilton Anxiety Rating Scale (HAM-A) total score [Срок оценки: Baseline to Week 8]
• Clinical Global Impression - Severity (CGI-S) score [Срок оценки: Baseline to Week 8]
• Patient Global Impression - Severity (PGI-S) score [Срок оценки: Baseline to Week 8]
• Change in Depression Anxiety Stress Scale - 21 items (DASS-21, Stress subscale only) [Срок оценки: Baseline to Week 8]
• Change in University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score [Срок оценки: Baseline to Week 8]
• Change in Pittsburgh Sleep Quality Index (PSQI) global score [Срок оценки: Baseline to Week 8]
• Change in State-Trait Anxiety Inventory (STAI) state [Срок оценки: Baseline to Week 8]

Критерии участия

Критерии включения

• Has provided written informed consent for the study and is willing to comply with all requirements of the protocol
• English speaker
• Male or female, ≥18 and ≤65 years of age
• Current diagnosis of generalized Social Anxiety Disorder (SAD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID-5-CT).
• Clinician-administered Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening
• Clinician-rated Hamilton Depression Rating Scale (HDRS 17) (17 items) total score <16 at Screening
• If participant is of childbearing potential, must commit to practicing effective methods of birth control during the study and at least 14 days after the last dose.

Критерии исключения

• Current diagnosis of performance-only SAD as defined by the DSM-5 and confirmed by the SCID-5-CT.
• Current diagnosis of any of the following psychiatric condition(s) as defined by the DSM-5 (participants with current generalized anxiety disorder may be included): Attention-deficit/hyperactivity disorder, Autism spectrum disorder, Major depressive disorder, Personality disorder, Post-traumatic stress disorder.
• Past or current diagnosis of any of the following psychiatric condition(s), as defined by the DSM-5: Bipolar disorder, Feeding and eating disorder (in adulthood), Obsessive-compulsive disorder, Schizophrenia spectrum or other psychotic disorder, Substance use disorder (within 12 months of Screening).
• Receiving daily psychotropics within 4 weeks of Screening
• Is at risk for suicidal ideation as per C-SSRS
• Has moderate or severe hepatic impairment
• Has severe renal impairment
• Women who are pregnant or women who are currently breastfeeding unless they are willing to stop breastfeeding for the duration of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 11 центров

• SOAR Clinical Study Site — Encino
• SOAR Clinical Study Site — Los Angeles
• SOAR Clinical Study Site — Oceanside
• SOAR Clinical Study Site — San Jose
• SOAR Clinical Study Site — Jacksonville
• SOAR Clinical Study Site — Tampa
• SOAR Clinical Study Site — Boston
• SOAR Clinical Study Site — Las Vegas
• … и ещё 3 центра

Идентификаторы

NCT: NCT07323784 · NTX-1472-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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