A Phase 2, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Social Anxiety Disorder

Avera Pharmaceuticals15 sites in 1 country180 target enrollmentFebruary 2006

ConditionsSocial Phobia

DrugsAV608

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Social Phobia
Sponsor: Avera Pharmaceuticals
Enrollment: 180
Locations: 15
Primary Endpoint: Liebowitz Social Anxiety Scale (LSAS)
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to look at the safety and effectiveness of an investigational drug (AV608) when used in subjects who have Social Anxiety Disorder. AV608 is an NK-1 receptor antagonist that exhibits central nervous system activity after oral administration. The study will compare AV608 to placebo (a medically inactive substance) to see if AV608 helps the symptoms of Social Anxiety Disorder. Eligible subjects will be assigned by chance to take either AV608 or placebo for 12 weeks. During the study, subjects will be asked about their overall health and mood and their Social Anxiety Disorder.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

December 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Avera Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•The subject is male or female, 18 - 65 years of age (inclusive).
•The subject meets current DSM-IV-TR (American Psychiatric Association, 2000) criteria for Social Phobia (300.23), generalized subtype, as confirmed by the Mini-International Neuropsychiatric Interview at Screening (Visit 1).
•The subject has had symptoms of SAD (Social Phobia) present for at least 6 months prior to Screening (Visit 1).
•The subject has a total score ≥ 60 on the LSAS at both Screening (Visit 1) and Baseline (Visit 2).
•The subject has a score ≥ 4 on the Clinical Global Impression - Severity (CGI-S) scale at both Screening (Visit 1) and Baseline (Visit 2).
•The subject has a score ≤ 15 on the 17-item Hamilton Rating Scale for Depression (HAM-D) at Screening
•The subject, if female and of child-bearing potential (not 2 years post-menopausal or surgically sterilized), must have a negative serum pregnancy test at Screening (Visit 1) and be willing to avoid pregnancy and practice adequate birth control from the time of study enrollment until 30 days after the last dose of study medication. Adequate methods of birth control are: oral contraception, intrauterine device, implantable contraceptive device, depot contraceptive, or a barrier method plus spermicide. Additional serum pregnancy tests will be administered at Visit 6, Visit 8, and Visit
•The subject, if engaged in ongoing psychotherapy for SAD or any other mental health condition, must have been attending therapy regularly for at least 3 months prior to Screening (Visit 1) and must agree to continue the same type and frequency of psychotherapy throughout the course of the study.
•The subject agrees to refrain from blood donation during the course of the study.
•The subject has written and oral fluency in English or Spanish.

Exclusion Criteria

•The subject has a decrease \>15 points on the LSAS total score between Screening (Visit 1) and Baseline (Visit 2).
•The subject has a clinically significant abnormality or clinically significant unstable medical condition as indicated by medical history, physical examination, ECG results, clinical laboratory testing, or the investigator's judgment at Screening (Visit 1) or Baseline (Visit 2).
•The subject has a QTc interval of 450 msec or greater at Screening (Visit 1) if male or a QTc interval of 470 msec or greater at Screening (Visit 1) if female.
•The subject has current hypothyroidism or hyperthyroidism or laboratory findings consistent with thyroid dysfunction. Subjects who are being treated for thyroid disorder are eligible if they have been on stable doses of thyroid hormone for at least 6 months and are currently euthyroid.
•The subject has any history of schizophrenia or other psychotic disorder, bipolar disorder, post-traumatic stress disorder, borderline personality disorder, or antisocial personality disorder.
•The subject has a history within the previous 5 years of obsessive-compulsive disorder or an eating disorder.
•The subject exhibits evidence of a clinically predominant DSM-IV-TR Axis I or II disorder other than Social Phobia or Avoidant Personality Disorder within the 6 months prior to Screening (Visit 1).
•The subject, in the opinion of the investigator, presents a significant risk of doing harm to himself, herself, or others.
•The subject has met DSM-IV-TR criteria for alcohol or substance dependence (other than nicotine or caffeine dependence) within 6 months of Screening (Visit 1).
•The subject has met DSM-IV-TR criteria substance abuse (other than alcohol, nicotine or caffeine abuse) within 3 months of Screening (Visit 1).