This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute administration of 3.2 µg of PH94B to relieve symptoms of anxiety in adult subjects with social anxiety disorder (SAD) during an induced public speaking challenge. Subject participation in the Study will last a total of 3 to 7 weeks, depending on the duration of the screening period and intervals between visits. Upon signing an informed consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting between 3 and 35 days. If subjects meet all eligibility criteria at the end of the screening period, subjects will return for Visit 2 and self-administer the nasal spray and then participate in a 5 minute public speaking challenge. During the public speaking challenge, the subject will be asked for their anxiety score, which will be recorded by a trained observer. At Visit 3, the subjects will undergo the same public speaking procedure once again as they did in Visit 2. One week after the completion of the Visit 3 public speaking challenge, the subject will come back for Visit 4 (Follow-up) that will involve a repeat of the safety and psychiatric assessments conducted at Screening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
228
Nasal spray delivered 20 minutes before the public speaking stressor
Nasal spray delivered 20 minutes before the public speaking stressor
VistaGen Clinical Site
Phoenix, Arizona, United States
VistaGen Clinical Site
Garden Grove, California, United States
VistaGen Clinical Site
Oceanside, California, United States
VistaGen Clinical Site
Temecula, California, United States
VistaGen Clinical Site
Alpharetta, Georgia, United States
VistaGen Clinical Site
Prairie Village, Kansas, United States
VistaGen Clinical Site
Boston, Massachusetts, United States
VistaGen Clinical Site
Flowood, Mississippi, United States
VistaGen Clinical Site
Berlin, New Jersey, United States
VistaGen Clinical Site
Brooklyn, New York, United States
...and 5 more locations
Subjective Units of Distress Scale (SUDS)
The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt
Time frame: Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)
Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment)
The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item scored from 1 (Very much less anxious) to 7 (Very much more anxious) with 4 being no change. Subjects are considered CGI-I responders with scores of 1 (Very much less anxious) or 2 (Much less anxious).
Time frame: Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)
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