- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00238719
Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder
May 17, 2006 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Venlafaxine ER In Children and Adolescent Outpatients With Social Anxiety Disorder
To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and adolescent outpatients with social anxiety disorder (generalized) in a placebo-controlled study.
Study Overview
Study Type
Interventional
Enrollment
293
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female outpatient
- 8-17 year old
- diagnosis of Social Anxiety Disorder
Exclusion Criteria:
- concomitant psychiatric or medical disorders which interfere with safety or assessment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.
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Secondary Outcome Measures
Outcome Measure |
---|
Response, defined as a score of 1 (very much improved) or (very improved), on the Clinical Global Impressions-Improvement (CGI-I) scale; Final on therapy Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-AC) total score.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1999
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
October 12, 2005
First Submitted That Met QC Criteria
October 12, 2005
First Posted (Estimate)
October 13, 2005
Study Record Updates
Last Update Posted (Estimate)
May 19, 2006
Last Update Submitted That Met QC Criteria
May 17, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Phobic Disorders
- Disease
- Anxiety Disorders
- Phobia, Social
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Venlafaxine Hydrochloride
Other Study ID Numbers
- 0600B4-389
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Social Anxiety Disorder
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Aya Technologies LimitedCompletedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder (Social Phobia)United Kingdom
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Tel Aviv UniversityCompletedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder (Social Phobia)Israel
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University of BernUniversity of LuebeckCompletedSocial Anxiety Disorder (Social Phobia)Switzerland
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Aya Technologies LimitedCompletedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder (Social Phobia)United Kingdom
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Daniel LiebermanTerminatedAnxiety | Anxiety Disorder SocialUnited States
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Weill Medical College of Cornell UniversityBrain & Behavior Research FoundationTerminatedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder of ChildhoodUnited States
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Tufts UniversityCompletedSocial Anxiety | Social Anxiety Disorder | Social Anxiety Disorder of ChildhoodUnited States
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Sumitomo Pharma America, Inc.BehaVR LLCCompletedSocial Anxiety Disorder (SAD)United States
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Emory UniversityBristol-Myers SquibbCompleted
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Florida International UniversityYale UniversityRecruitingSocial Anxiety Disorder of ChildhoodUnited States
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