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

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NCT00238719

Last updated on February 18, 2020

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About this Study

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 Location

Contact

1-800-718-1021

[email protected]

Eligibility criteria

Condition

Social Anxiety Disorder

Sex

Females and Males

Age

8-17 years

Inclusion criteria

Show details

- Male or female outpatient

- 8-17 year old

- diagnosis of Social Anxiety Disorder

Exclusion criteria

Show details

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

NCT00238719

Pfizer

Completed

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

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[email protected]

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Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Social Anxiety Disorder

Intervention ^ICMJE

Drug: Venlafaxine ER

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

293

Original Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

June 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

8 Years to 17 Years (Child)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00238719

Other Study ID Numbers ^ICMJE

0600B4-389

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

PRS Account

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

May 2006

^ICMJE Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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

NCT00238719

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

NCT00238719

About this Study

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