Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Newleos Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with Social Anxiety Disorder. Participants will take a study treatment or a placebo every day for 8 weeks and attend 6 clinic visits for checkups and tests over 14 weeks.
Are You a Good Fit for This Trial?
Must not be takingPsychotropic medications
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with generalized Social Anxiety Disorder.
I speak English.
I can commit to effective birth control if I can get pregnant.
I have a total score of 70 or more on the Liebowitz Social Anxiety Score.
I have a total score of less than 16 on the Hamilton Depression Rating Scale.
You may not be able to join if
I have been diagnosed with performance-only Social Anxiety Disorder.
I have a current diagnosis of certain psychiatric conditions like bipolar disorder or schizophrenia.
I have had substance use disorder in the last 12 months.
I am at risk for suicidal thoughts.
I have moderate or severe liver disease.
I have severe kidney disease.
I am currently pregnant or breastfeeding unless I can stop breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 plac…
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
Trial Locations
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Eligibility Criteria
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 …
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.
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