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Sponsored by: |
Avera Pharmaceuticals |
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Information provided by: | Avera Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00294346 |
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.
Condition | Intervention | Phase |
---|---|---|
Social Phobia |
Drug: AV608 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Social Anxiety Disorder |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The subject has used any prohibited medications, or has any anticipated need or intended use of these medications during the study, including:
United States, Alabama | |
Birmingham Research Group, Inc. | |
Birmingham, Alabama, United States, 35216 | |
United States, Arizona | |
Pivotal Research Centers | |
Mesa, Arizona, United States, 85210 | |
United States, California | |
Affiliated Research Institute | |
San Diego, California, United States, 92108 | |
Southwestern Research, Inc. | |
Beverly Hills, California, United States, 90210 | |
United States, Florida | |
CNS Healthcare | |
Jacksonville, Florida, United States, 32216 | |
Comprehensive Neuroscience, Inc. | |
Saint Petersburg, Florida, United States, 33702 | |
University of South Florida | |
Tampa, Florida, United States, 33613 | |
United States, Maryland | |
DuPont Clinical Research, Inc. | |
Rockville, Maryland, United States, 20852 | |
Capital Clinical Research Associates | |
Rockville, Maryland, United States | |
United States, New York | |
Medical Research Network, LLC | |
New York, New York, United States, 10024 | |
United States, Ohio | |
Hartford Research | |
Cincinnatti, Ohio, United States, 45242 | |
United States, Oklahoma | |
IPS Research Company | |
Oklahoma City, Oklahoma, United States, 73130 | |
United States, Oregon | |
Summit Research Network | |
Portland, Oregon, United States, 97210 | |
United States, Texas | |
Croft Group Research Center | |
San Antonio, Texas, United States, 78229 | |
Claghorn-Lesem Research Clinic, LLP | |
Bellaire, Texas, United States, 77401 |
Study ID Numbers: | AV608-105 |
Study First Received: | February 17, 2006 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00294346 |
Health Authority: | United States: Food and Drug Administration |
Social Anxiety Disorder Social Phobia |
Anxiety Disorders Mental Disorders Phobic Disorders |