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Recruiting NCT07323784

A Study of NTX-1472 in Social Anxiety Disorder

Phase II Interventional Social Anxiety Disorder (SAD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NTX-1472, Placebo.
Who it may be relevant to
Registry conditions: Social Anxiety Disorder (SAD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Incidence and severity of treatment-emergent adverse events (TEAEs) [Time frame: Baseline to Week 8]
Secondary outcome measures (11)
  • Change in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score [Time frame: Baseline to Week 8]
  • Change in LSAS Fear/Anxiety and Avoidance subscale score [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 [Time frame: Baseline to Week 8]
  • Number and percentage of participants who are remitters based on an LSAS total score of <30 [Time frame: Baseline to Week 8]
  • Change in Hamilton Anxiety Rating Scale (HAM-A) total score [Time frame: Baseline to Week 8]
  • Clinical Global Impression - Severity (CGI-S) score [Time frame: Baseline to Week 8]
  • Patient Global Impression - Severity (PGI-S) score [Time frame: Baseline to Week 8]
  • Change in Depression Anxiety Stress Scale - 21 items (DASS-21, Stress subscale only) [Time frame: Baseline to Week 8]
  • Change in University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score [Time frame: Baseline to Week 8]
  • Change in Pittsburgh Sleep Quality Index (PSQI) global score [Time frame: Baseline to Week 8]
  • Change in State-Trait Anxiety Inventory (STAI) state [Time frame: Baseline to Week 8]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 11 centers
  • 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
  • … and 3 more centers

Identifiers

NCT: NCT07323784 · NTX-1472-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗