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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00238719
First received: October 12, 2005
Last updated: May 17, 2006
Last verified: May 2006
  Purpose
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
  Eligibility

Ages Eligible for Study:   8 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238719

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

ClinicalTrials.gov 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:
Disease
Anxiety Disorders
Phobic Disorders
Pathologic Processes
Mental Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 24, 2016