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Safety and Efficacy Study of AV608 in Subjects With Social Anxiety Disorder
NCT00294346 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG AV608
Study Locations (15)
Florida
- CNS Healthcare — Jacksonville
- Comprehensive Neuroscience, Inc. — St. Petersburg
- University of South Florida — Tampa
California
- Southwestern Research, Inc. — Beverly Hills
- Affiliated Research Institute — San Diego
Maryland
- DuPont Clinical Research, Inc. — Rockville
- Capital Clinical Research Associates — Rockville
Texas
- Claghorn-Lesem Research Clinic, LLP — Bellaire
- Croft Group Research Center — San Antonio
Alabama
- Birmingham Research Group, Inc. — Birmingham
Arizona
- Pivotal Research Centers — Mesa
New York
- Medical Research Network, LLC — New York
Ohio
- Hartford Research — Cincinnatti
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2006-02 |
| Est. Completion | 2006-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00294346
The ClinicalTrials.gov registry entry for NCT00294346 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avera Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Social Phobia appearing as the primary indexed condition, and to 1 intervention — of which AV608 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00294346 reports 15 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00294346 about?
NCT00294346 is a clinical study titled "Safety and Efficacy Study of AV608 in Subjects With Social Anxiety Disorder". 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 t...
What is the current status of trial NCT00294346?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2006-02. Estimated completion is 2006-12.
What conditions does trial NCT00294346 study?
This clinical trial studies the following conditions: Social Phobia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00294346?
The interventions under investigation include: AV608 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00294346?
This trial is sponsored by Avera Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00294346 being conducted?
This trial has 15 study locations across Alabama, Arizona, California, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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