Back to resultsStudy Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Venlafaxine ER
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety, Children Disorders
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00238719
First Posted
October 12, 2005
Last Updated
May 17, 2006
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00238719
Brief Title
Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder
Official Title
A Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of Venlafaxine ER In Children and Adolescent Outpatients With Social Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social Anxiety, Children Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
293 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Venlafaxine ER
Primary Outcome Measure Information:
Title
Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder
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