NCT01217788

Intranasal PH94B for Management of the Symptoms of Generalized Social Phobia

Double Blind Placebo Controlled Study of PH94B for Management of the Symptoms of Generalized Social Phobia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Pherin Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of PH94B, a new class of therapeutic compound, administered intranasally for the management of acute anxiety in patients diagnosed with generalized social phobia.

Detailed description

The essential features of generalized social phobia are defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), criteria as a marked and persistent fear of most (generally accepted as four or more) social or performance situations in which the patient believes embarrassment could occur as a consequence of exposure to unfamiliar people and/or possible scrutiny by others. The anxiety resulting from the social or performance situation is profound. The avoidance, fear, or anxious anticipation of these situations interferes significantly with the person's daily routine, having a marked impact on occupational functioning and/or social life. The disorder has a lifetime prevalence estimated at up to 13%, with onset typically in the mid-teens, and it is diagnosed slightly more frequently in females than in males. Social phobia tends to be a chronic disorder with periods of exacerbation, with a reported mean duration of illness of approximately 20 years. There are two subtypes of social phobia: (i) generalized (discrete), which is suffered by approximately 50% of social phobia patients and in which fear and avoidance extend to a wide range of social situations, and (ii) non-generalized, in which the patient fears only one or a few circumscribed situations. Speaking in front of large groups is by far the most prevalent of social fears (Lang and Stein, 2001). Social phobia has a lifetime comorbidity rate of approximately 81% with other psychiatric disorders (particularly affective disorders, other anxiety disorders, and substance abuse disorders), as well as to being associated with increased nonpsychiatric medical difficulties. People with social phobia identify social impairment, inadequate social support, overall role impairment, specific impairment in education, work, and other activities, as well as interference in their efforts at self-improvement. Unfortunately, for these patients, there is a strong consensus that social phobia is one of the least commonly recognized and treated mental disorders

Conditions

• Social Phobia
• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	PH94B intranasal spray	Comparison of PH94B single dose intranasal spray and Placebo single dose intranasal spray

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2010-10-08
• Last updated: 2011-05-10

Locations

1 site across 1 country: United States