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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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|
- Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.
- 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.
|Study Start Date:||December 1999|
|Estimated Study Completion Date:||June 2003|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238719
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|