NTX-1472 for adults with social anxiety disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, placebo-controlled trial gives adults with generalized social anxiety disorder either NTX-1472 or a matching placebo once daily for 8 weeks and follows them for a total of 14 weeks. Participants attend six clinic visits for safety checks, symptom ratings, and other tests. Eligibility requires a confirmed DSM-5 diagnosis of generalized SAD and a high baseline Liebowitz Social Anxiety Scale (LSAS) score. The trial's main outcomes are safety/tolerability and change in social anxiety symptoms compared with placebo.

Why it matters

Who can join: the full rules

Key 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.

Key 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.

Where it's running

• SOAR Clinical Study Site
  Encino, California, United States Recruiting
• SOAR Clinical Study Site
  Los Angeles, California, United States Recruiting
• SOAR Clinical Study Site
  Oceanside, California, United States Recruiting
• SOAR Clinical Study Site
  San Jose, California, United States Recruiting
• SOAR Clinical Study Site
  Jacksonville, Florida, United States Recruiting
• SOAR Clinical Study Site
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Newleos Therapeutics Clinical Trial Team
• Email: clinicaltrials@newleos.com
• Phone: 978-780-5937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Caplyta versus placebo for adults with social anxiety disorder

  This study tests whether Caplyta works better than a placebo for adults with social anxiety disorder over 8 weeks.

  Recruiting Phase 4 IMA Clinical Research · New York, New York · NCT07799493

• Expectancy Focused Exposure for Anxiety Disorders

  We test whether Expectancy Focused Exposure helps reduce anxiety symptoms and prevent fear from coming back better than Anxiety Focused Exposure in adults with anxiety disorders.

  Recruiting University of Chile · Santiago, Santiago Metropolitan · NCT07753330

• Attention Bias Modification for Social Anxiety Disorder: Does training help, or is it a placebo effect?

  This study tests whether a computerized attention training (ABM) reduces social anxiety symptoms in adults with SAD, and whether any improvement comes from actual attentional changes or from placebo/expectancy factors.

  Recruiting Tel Aviv University · Tel Aviv · NCT07666776

• Short bursts of noninvasive brain stimulation to the prefrontal cortex for social anxiety

  This treatment will test whether daily intermittent theta-burst brain stimulation to the prefrontal cortex can reduce social anxiety symptoms in people with SAD while tracking brain changes with EEG.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07466277

• ACTsocially: Using Acceptance and Commitment Therapy to help teens with social anxiety and oppositional behavior

  This project will test whether a transdiagnostic Acceptance and Commitment Therapy (ACT) program can reduce social anxiety and oppositional defiant behaviors in adolescents who have both conditions.

  Recruiting University of Coimbra · Coimbra · NCT07456631

• Online Radical Acceptance program for social anxiety

  This project will test whether a self-guided online Radical Acceptance program helps adults with social anxiety more than an online relaxation program.

  Recruiting University of Haifa · Haifa · NCT07325929

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.