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

Wyeth is now a wholly owned subsidiary of Pfizer293 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

293

Conditions

Social Anxiety Disorder

Interventions

Venlafaxine ERDRUG

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

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.

Data from ClinicalTrials.gov

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