Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder

Phase 3

Completed

• Conditions: Social Anxiety Disorder

• Registration Number: NCT00238719
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Study Completion: 2003-06
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-17
• Last Update Posted: 2006-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.

Secondary Outcome Measures

Name	Time	Method
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.