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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
NTX-1472
DrugDaily (QD) x 8 weeks.
Placebo
DrugDaily (QD) x 8 weeks.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: NTX-1472Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame
Baseline to Week 8Secondary outcomes
1
Change in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Time frame
Baseline to Week 82
Change in LSAS Fear/Anxiety and Avoidance subscale score
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Time frame
Baseline to Week 83
Number and percentage of participants who are responders (≥50% improvement from Baseline [Day 1]) based on the LSAS total score
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Time frame
Baseline to Week 84
Number and percentage of participants who are remitters based on an LSAS total score of <30
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Time frame
Baseline to Week 8Sponsors and contacts
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Source ClinicalTrials.gov