People with social anxiety disorder (SAD) experience symptoms of intense fear of social or performance (e.g., public speaking) situations in which the person believes embarrassment, humiliation, judgement, or rejection could occur. The avoidance or anxious anticipation of these types of situations significantly interferes with daily routines, work, and social life. SAD is a chronic disorder that often begins in childhood or adolescence.
This clinical research study is being conducted to see if the investigational drug that is being evaluated, called PH94B, can relieve acute anxiety symptoms in adults with social anxiety disorder (SAD).
PH94B is a non-hormonal, neuroactive steroid delivered by nasal spray. Study participants will receive either PH94B or a placebo (a substance that looks like PH94B but has no active medicine) and the results will be compared.
Before any study-specific procedures begin, the study staff will review the Informed Consent Form to provide a detailed explanation of this clinical research study and its potential risks and benefits. The doctor and study staff will answer any questions. After receiving this information, if you wish to participate in the study, you will be required to sign an informed consent form.
In total, this study will involve 4 visits to the study center over a period of about 3 to 7 weeks. After consent has been given, the screening period of the study begins. During the screening visit, the study staff reviews medical history and conducts a series of study-related examinations and assessments to see if the study requirements are met. The screening visit can occur from 3 to 35 days before the 2nd study visit.
Those participants who are determined to satisfy all study requirements will return to the study center for 2 treatment visits. This is a blinded clinical research study which means that qualified participants have a 50% chance, like flipping a coin, of receiving either PH94B or placebo. After these visits, there will be 1 follow-up visit for assessments and a safety check. These 3 visits will be about 1 week apart.
Health insurance is not required to participate.
All clinical examinations, study procedures, and the study drug are provided at no cost. Compensation for study-related travel expenses while taking part in this clinical research study may also be available to those who qualify and participate.