Intranasal PH94B for Management of the Symptoms of Generalized Social Phobia

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pherin Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Subject currently meets the Diagnosis of Social Phobia as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition which is not secondary to another pre-existing psychiatric condition or to a medical condition.

• Liebowitz Social Anxiety Scale (LSAS) score greater than or equal to 60 at Screening.

• Score of 75 or greater on the SUD scale at one of the Performance Phase time points during either the Public Speaking or Social Interaction Challenge

• Written Informed Consent prior to commencing any study specific procedures.

• Women of child-bearing-potential must be able to commit to the consistent and correct use of an acceptable method of birth control throughout the study and have a negative serum pregnancy test result prior to study drug administration.

Exclusion Criteria:

• Use of any psychotropic medication within 30 days prior to study entry.

• Acute or chronic psychiatric disease which is the primary diagnosis (except Social Phobia) at the time of the study. Note that subjects with concurrent Generalized Anxiety Disorder (GAD) are allowed into the study provided this is not the primary diagnosis.

• Subjects with a history of psychiatric diseases such as schizophrenia, bipolar disorder, and psychosis are to be excluded.

• Presence of a clinical condition or disease, or use of a concomitant medication, that in the clinical judgment of the Investigator could place the patient at undue risk, interfere with study participation, or confound the results of the study.

• Use of substances of abuse within the year prior to study entry.

• Concomitant use of any over-the-counter, prescription product, or herbal preparation for treatment of the symptoms of social anxiety during the study and within 30 days prior to study entry and use of non-study anxiolytics such as benzodiazepines during the study and within 30 days prior to study entry.