NCT00238719

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 1999

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
Last Updated

May 19, 2006

Status Verified

May 1, 2006

First QC Date

October 12, 2005

Last Update Submit

May 17, 2006

Conditions

Social Anxiety Disorder

Keywords

Social AnxietyChildren Disorders

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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.

Interventions

Venlafaxine ERDRUG

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female outpatient
  • year old
  • diagnosis of Social Anxiety Disorder

You may not qualify if:

  • concomitant psychiatric or medical disorders which interfere with safety or assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

December 1, 1999

Study Completion

June 1, 2003

Last Updated

May 19, 2006

Record last verified: 2006-05