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

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: October 12, 2005
Last updated: May 17, 2006
Last verified: May 2006

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.

Condition Intervention Phase
Social Anxiety Disorder
Drug: Venlafaxine ER
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Venlafaxine ER In Children and Adolescent Outpatients With Social Anxiety Disorder

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 293
Study Start Date: December 1999
Estimated Study Completion Date: June 2003

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00238719

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided Identifier: NCT00238719     History of Changes
Other Study ID Numbers: 0600B4-389
Study First Received: October 12, 2005
Last Updated: May 17, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Social Anxiety
Children Disorders

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses processed this record on April 17, 2014