ACTIVE_NOT_RECRUITING

A Study to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder

Talk to us

Conditions

Social Anxiety Disorder (SAD)Social AnxietyENX-102

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a double-blind study to evaluate the efficacy and safety of ENX-102 in participants with social anxiety disorder (SAD).

Official Title

The ENCalmSocial Trial: A Randomized, Double-Blind, Placebo-Controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Participants With Social Anxiety Disorder

Quick Facts

Study Start:2025-09-05
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07193563

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female at birth, aged 18-70 years, inclusive, at screening Diagnosed with SAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
  2. * LSAS total score of ≥70
  3. * CGI-S score of ≥4
  1. * Clinically predominant psychiatric diagnosis other than SAD per the MINI
  2. * Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
  3. * Reports moderately severe to severe symptoms of depression
  4. * Frequent use of benzodiazepines within 90 days of screening
  5. * Used prohibited medication or prohibited herbal or other supplements within 5 half- lives or 21 days prior to Day 1 and unwillingness to refrain from their use for the duration of the trial
  6. * Recent suicidal ideation or behavior
  7. * Current or recent moderate or severe substance use disorder as assessed by the MINI
  8. * Is unwilling/unable to abstain from alcohol, marijuana, THC, CBD, and/or any other psychoactive substances (except for nicotine or caffeine) for the duration of the trial, per Investigator judgment, and/or has a positive alcohol test or drug test at Screening or Day 1
  9. * Clinically significant abnormal findings in safety assessments
  10. * Has significant progressive disorders or unstable medical conditions Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study

Contacts and Locations

Study Locations (Sites)

IMA Clinical Research Phoenix
Phoenix, Arizona, 85012
United States
University of California
La Jolla, California, 92037
United States
Neuroresearch Group
Los Angeles, California, 90025
United States
Excell Research, Inc.
Oceanside, California, 92056
United States
Anderson Clinical Research
Redlands, California, 92374
United States
California Neuroscience Research, LLC
Sherman Oaks, California, 91403
United States
Sunwise Clincial Research
Walnut Creek, California, 94596
United States
Mountain View Clinical Research
Denver, Colorado, 80209
United States
CNS Health
Jacksonville, Florida, 32256
United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
United States
CenExel iResearch, LLC
Savannah, Georgia, 31405
United States
IMA Clinical Research
Las Vegas, Nevada, 89102
United States
Redbird Research
Las Vegas, Nevada, 89119
United States
Cenexel HRI
Berlin, New Jersey, 08009
United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
United States
Clinical Neurosciences, Inc
Memphis, Tennessee, 38119
United States
Austin Clinical Trials Partners
Austin, Texas, 78737
United States
Grayline Research Center
Wichita Falls, Texas, 76309
United States
Core Clinical Research
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Engrail Therapeutics INC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-05
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-09-05
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Social Anxiety
  • ENX-102

Additional Relevant MeSH Terms

  • Social Anxiety Disorder (SAD)