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New treatment option for Social Anxiety Disorder (SAD)
Official title A Study of NTX-1472 in Social Anxiety Disorder
ClinicalTrials.gov ID: NCT07323784
What this study is testing
What is NTX-1472?
NTX-1472 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for social anxiety disorder (sad).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Key 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...
- Clinician-administered Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening
You likely can't join if
- 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...
- Past or current diagnosis of any of the following psychiatric condition(s), as defined by the DSM-5: Bipolar disorder, Feeding and eating disorder...
- Receiving daily psychotropics within 4 weeks of Screening
- Is at risk for suicidal ideation as per C-SSRS
- Has moderate or severe hepatic impairment
See the full eligibility criteria
- Key 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...
- 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
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Encino, California, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- San Jose, California, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Las Vegas, Nevada, United States
- Brooklyn, New York, United States
- Memphis, Tennessee, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Encino, California, United States; Los Angeles, California, United States; Oceanside, California, United States; San Jose, California, United States; Jacksonville, Florida, United States; Tampa, Florida, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.