Study Evaluating Venlafaxine ER in Children and Adolescents 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.

Completed

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venlafaxine ER

Drug

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Venlafaxine ER In Children and Adolescent Outpatients With Social Anxiety Disorder

Important dates

Study start: 1999
Study completion: 2003
First posted: Oct 13, 2005
Registry last updated: May 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed