A Study of NTX-1472 in Social Anxiety Disorder
ConditionSocial Anxiety Disorder (SAD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNewleos Therapeutics, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- NTX-1472
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov