Safety and Efficacy Study of AV608 in Subjects With Social Anxiety Disorder

NCT00294346 | Completed Phase 2

• 1 other identifier: AV608-105
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 15

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.

Conditions

Social Phobia

Keywords

Social Anxiety Disorder; Social Phobia

Outcome Measures

Primary Outcomes (1)

• Liebowitz Social Anxiety Scale (LSAS)

Interventions

AV608 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 9.
• 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.
• The subject is willing to participate in the study, as evidenced by a signed and dated written Informed Consent Form (ICF).

You may not qualify if:

• 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).
• The subject tests positive on the urine drug screen conducted at Screening (Visit 1) for illicit drugs, including opiates, barbiturates, amphetamines, cocaine, and phencyclidine.
• The subject is a pregnant or lactating female.
• The subject has previously participated in a clinical trial for AV608 (previously identified as NKP608 and CGP608).
• The subject has used any prohibited medications, or has any anticipated need or intended use of these medications during the study, including:
• Depot injection of an antipsychotic medication within 3 months prior to Baseline (Visit 2) or use of any other antipsychotic or mood stabilizing medication within 30 days prior to Baseline (Visit 2)

Sponsors & Collaborators

• Avera Pharmaceuticals: lead

Study Sites (15)

Birmingham Research Group, Inc.

Birmingham, Alabama, 35216, United States

Location

Pivotal Research Centers

Mesa, Arizona, 85210, United States

Location

Southwestern Research, Inc.

Beverly Hills, California, 90210, United States

Location

Affiliated Research Institute

San Diego, California, 92108, United States

Location

CNS Healthcare

Jacksonville, Florida, 32216, United States

Location

Comprehensive Neuroscience, Inc.

St. Petersburg, Florida, 33702, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

DuPont Clinical Research, Inc.

Rockville, Maryland, 20852, United States

Location

Capital Clinical Research Associates

Rockville, Maryland, United States

Location

Medical Research Network, LLC

New York, New York, 10024, United States

Location

Hartford Research

Cincinnatti, Ohio, 45242, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73130, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Claghorn-Lesem Research Clinic, LLP

Bellaire, Texas, 77401, United States

Location

Croft Group Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 22, 2006
• Study Start: February 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: February 25, 2008

Record last verified: 2008-02

Locations

US (15)