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NCT00238719 Clinical Trial

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

Social Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238719
Other study ID # 0600B4-389
Secondary ID
Status Completed
Phase Phase 3
First received October 12, 2005
Last updated May 17, 2006
Start date December 1999
Est. completion date June 2003

Study information
Verified date May 2006
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 293
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 17 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Venlafaxine ER

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.
Secondary 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.
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