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Feasibility Study of PH94B Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD)

NCT02622958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-12-07

No results posted yet for this study

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).

Conditions

Interventions

DRUG

PH94B

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Pherin Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Liebowitz · The Medical Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-10-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622958 on ClinicalTrials.gov