Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double Blind Placebo Controlled Study of PH94B for Management of the Symptoms of Generalized Social Phobia
Brief 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.


Options:
A: Inclusion Criteria:

* Diagnosis of Social Anxiety Disorder, generalized subtype
* LSAS total score of 70 at visits 1 and 2

Exclusion Criteria:

* Lifetime history of Bipolar disorder or Schizophrenia
* Current suicidal risk
* Current unstable medical condition
B: Inclusion criteria:

* Social phobic ambulatory subjects, defined according to DSM-IV criteria.
* Must be capable of giving informed consent and can comply with the study requirements.
* Women of childbearing potential must agree to acceptable method of birth control.

Exclusion criteria:

* Primary diagnosis within the past 6 months of other psychiatric conditions such as major depression or another anxiety disorder.
* Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
* Subjects who, in the investigator's judgement pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
* Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
* Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG) findings.
C: Inclusion Criteria:

* Male or female outpatients at least 18 years of age and not more than 65 years of age.
* Must sign the informed consent document.
* Present at Visit 1 with social anxiety disorder based on a Clinical Global Impression-Severity score of greater than or equal to 4.
* Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use both a reliable primary method of birth control.
* Judged to be reliable and willing to keep all appointments for clinic visits, tests, and procedures required by the protocol.

Exclusion Criteria:

* Have any comorbid Axis I disorders (such as major depression, obsessive compulsive disorder, post-traumatic stress disorder, or panic disorder), in the opinion of the investigator, if the disorder occurred within the last 6 months.
* Have had any previous or current diagnoses of bipolar disorders, schizophrenia, or other psychotic disorders.
* Have the presence of an Axis II disorder, except avoidant personality disorder.
* Have a serious medical illness.
* Have abnormal thyroid-stimulating hormone (TSH) concentrations or are taking thyroid supplements.
D: 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.

Answer: D