Clinical Trials Logo
  1. Home
  2. Social Anxiety Disorder
  3. NCT00238719
  4. Details
NCT00238719 Clinical Trial

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

Social Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238719
Other study ID # 0600B4-389
Secondary ID
Status Completed
Phase Phase 3
First received October 12, 2005
Last updated May 17, 2006
Start date December 1999
Est. completion date June 2003

Study information
Verified date May 2006
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 293
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 17 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Venlafaxine ER

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Final on therapy Social Anxiety Scale-Adolescents and Children (SAS-AC) total score.
Secondary 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.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06274112 - Using TMS to Understand Neural Processes of Social Motivation N/A
Completed NCT02554929 - Treatment of Social Anxiety Disorder and Selective Mutism N/A
Completed NCT00684541 - Interpretation Modification Program for Social Phobia N/A
Completed NCT00684320 - Attention Disengagement Training for Social Phobia N/A
Completed NCT03247075 - Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT N/A
Completed NCT02811458 - Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders N/A
Withdrawn NCT04622930 - Waitlist-Control Trial of Smartphone CBT for Social Anxiety Disorder (SAD) N/A
Active, not recruiting NCT05018312 - Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety N/A
Active, not recruiting NCT05124639 - Clinical Trial of a Group Self-management Support Program for Anxiety Disorders N/A
Completed NCT05858294 - The Safety, Acceptability and Efficacy of Alena N/A
Active, not recruiting NCT05600114 - Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder Phase 2
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Not yet recruiting NCT02924610 - Brief Intervention to Reduce Fear Phase 4
Active, not recruiting NCT02592564 - Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder N/A
Recruiting NCT02305537 - Building an Outcomes Assessment Infrastructure to Assess Anxiety Treatment N/A
Terminated NCT03764644 - Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders N/A
Unknown status NCT01712321 - Study of Vilazodone to Treat Social Anxiety Disorder N/A
Completed NCT01320800 - CBT for Social Anxiety Disorder Delivered by School Counselors Phase 2
Completed NCT00872820 - Examining Long-Term Effects and Neural Mediators of Behavioral Treatments for Social Anxiety Disorder N/A
Completed NCT00485888 - Flushing in Social Anxiety Disorder on Cipralex Phase 2