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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238719

Enrollment

293

Registered

2005-10-13

Start date

1999-12-31

Completion date

2003-06-30

Last updated

2006-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety, Children Disorders

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.

Interventions

DRUGVenlafaxine ER

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

8 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.	—

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026