Feasibility Study of PH94B Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD)
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|ClinicalTrials.gov Identifier: NCT02622958|
Recruitment Status : Completed
First Posted : December 7, 2015
Last Update Posted : December 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Disorder||Drug: PH94B Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Feasibility Study for a Phase 3, Randomized, Four-Week, Double-Blind, Placebo-Controlled, Crossover Trial of the Efficacy and Safety of PH94B Nasal Spray in the Acute Treatment of Social Anxiety Disorder (SAD)|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||March 2015|
Experimental: PH94B Nasal Spray
Water based solution of 16 ppm PH94B. Each nasal spray delivers .8 micrograms PH94B in 50 microliters
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:
Placebo Comparator: Placebo Nasal Spray
Water based solution, each nasal spray delivers 50 microliters of droplets.
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:
- Subjective units of distress [ Time Frame: Study medication nasal spray is to be administered 15 minutes prior to public performance and following each event they will be asked to record maximum subjective anxiety level experienced during the event. ]The primary study endpoint is average peak anxiety level for public performance or social interaction events during the two 2-week double-blind treatment phases (PH94B and placebo). Subjects will be asked to self-administer double-blind PH94B or placebo 15 minutes prior to public performance or social interaction events. Following each event, they will be asked to record the maximum (peak) subjective anxiety level experienced during the event using the patient rated Subjective Units of Distress Scale (SUDS), where anxiety scores range from 0 (no anxiety) to 100 (maximum anxiety ever experienced). Within each 2-week treatment phase, all subjective anxiety ratings will be summed and divided by the number of events recorded.
- Clinical Global Impression of Improvement rating & Liebowitz Social Anxiety Scale [ Time Frame: At baseline and following 2 weeks of treatment with Study medication nasal spray ]Two key secondary endpoints of the study are overall subject improvement as assessed by the Clinical Global Impression of Improvement rating (CGI-I), and the Investigator rated Liebowitz Social Anxiety Scale (LSAS). The proportion of subjects receiving a clinician-rated CGI-I score of 1 (Very much improved) or 2 (Much improved) following two weeks of treatment with placebo will be compared to the proportion of patients receiving a clinician-rated CGI-I score of 1 or 2 following two weeks of treatment with PH94B.
- Changes from screening/baseline in clinical laboratory values, ECGs, physical examinations, and vital sign assessments. [ Time Frame: Every two weeks during treatment and one week after treatment with Study Medication Nasal Spray ]Safety and tolerability of PH94B will be assessed through changes from screening/baseline in laboratory values, ECGs, physical examinations, and vital sign assessments following exposure to PH94B, as well as by comparison of adverse events reported during treatment with PH94B and placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622958
|United States, New York|
|The Medical Research Network, LLC|
|New York City, New York, United States, 10128|
|Principal Investigator:||Michael Liebowitz||The Medical Research Network|