Feasibility Study of PH94B Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD)
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether the PH94B nasal spray is effective for Acute
      Treatment of the symptoms of Social Anxiety Disorder (SAD) in adult men and women. The
      hypothesis is that PH94B nasal spray (.8 micrograms) has a rapid onset of efficacy to improve
      performance and interaction anxiety in patients with diagnosed Social Anxiety Disorder (SAD).
    

Detailed description: 
      The study is a randomized, double-blind, placebo-controlled, 2-way crossover trial of the
      efficacy and safety of PH94B in the treatment of subjects diagnosed with Social Anxiety
      Disorder as defined by the Diagnostic and Statistical Manual IV and confirmed by the MINI
      (5.0.0). The study is intended to serve as a feasibility trial of a multi-center phase 3
      study protocol of similar design.

      The primary objective of this study is to evaluate design features for a larger Phase 3 study
      that will evaluate the safety and efficacy of PH94B for the acute management of symptoms in
      subjects with Social Anxiety Disorder. Careful review of diary entries and measurement of
      study medication compliance each week will be used to determine the feasibility of using the
      study medication on an "as needed" basis for anxiety-provoking social events. Specifically,
      the frequency of use, variability of SUDS ratings, effect size of differences in average peak
      SUDS ratings during treatment with PH94B and placebo, and general reliability of the diary
      recording method will be evaluated and used to refine inclusion and exclusion criteria as
      well as provide guidance for designing a larger multi-site study.

      The study will last a total of 6-8 weeks. The randomized double-blind treatment period will
      last a total of four weeks for all subjects.
    

Intervention name(s): PH94B; Placebo
Intervention type(s): Drug; Other
Intervention description(s): PH94B is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg PH94B).
Dosing is sex-specific:
Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg
Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg; Placebo is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg Placebo).
Dosing is sex-specific:
Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg
Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Social Phobia; Performance Anxiety; Social Anxiety; Anxiety