Treatment of Childhood Social Phobia - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00043537

Purpose

This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.

Condition	Intervention	Phase
Social Phobia	Behavioral: Social Effectiveness Therapy for Children (SET-C) Drug: Fluoxetine Drug: Pill Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Childhood Social Phobia

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	250
Study Start Date:	April 2001
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Social phobia affects 3-5 percent of children, and prevalence rises with age. Youth with social phobia fear many activities that are part of everyday life and suffer from problems such as headaches or stomachaches, panic, avoidance, general anxiety, depression, loneliness, and a very restricted range of social relationships. Recent findings indicate a new psychosocial treatment called Social Effectiveness Therapy for Children (SET-C) is effective in treating children ages 8-11, resulting in reduced emotional distress and improved social functioning. Treatment effects have been maintained for up to 6 months. This study will examine SET-C in children ages 8-15. Because available data suggest that the drug fluoxetine is a promising treatment, SET-C will be compared to fluoxetine in this trial. Durability of treatment will be monitored over a 1-year follow-up period.

Eligibility

Ages Eligible for Study:	8 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Diagnosis of social phobia

Exclusion Criteria:

Pervasive developmental disorders (PDD)
Schizophrenia
Major Depression
IQ of less than 80
Medical conditions contraindicating use of fluoxetine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043537

Locations

United States, Maryland
Maryland Center for Anxiety Disorders
University of Maryland, College Park, Maryland, United States, 20742

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Beidel DC, Turner SM, Sallee FR, Ammerman RT, Crosby LA, Pathak S. SET-C versus fluoxetine in the treatment of childhood social phobia. J Am Acad Child Adolesc Psychiatry. 2007 Dec;46(12):1622-32.

Study ID Numbers:	R01 MH53703, DSIR CT-CT
Study First Received:	August 9, 2002
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00043537 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Phobic Disorders
Mutism

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Phobic Disorders
Serotonin Uptake Inhibitors
Pharmacologic Actions

Fluoxetine
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 25, 2009