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Treatment for Anxiety in Children



Treatment for Anxiety in Children

For Condition: Obsessive-Compulsive Disorder,Anxiety Disorders,Generalized Anxiety Disorder,Social Phobia,Separation Anxiety
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to see if it is effective to treat children with anxiety disorders with fluvoxamine. Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social phobia, or separation anxiety, are very common in youth and are not always responsive to behavioral therapies alone. These disorders may respond to fluvoxamine. A child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this double-blind phase (neither the child/parents nor the doctor know which treatment is being given), the child will have the option of continuing treatment during a 4-month open-label extension period (both the child/parents and the doctor know which the child is receiving). A child may be eligible for this study if he/she: Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized anxiety disorder, social phobia, or separation anxiety).
Details: To evaluate fluvoxamine in the treatment of children and adolescents with anxiety disorders. Fluvoxamine is a serotonin reuptake inhibitor that is FDA-approved for the treatment of obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD are very common in youth and are not always responsive to psychosocial therapies. Fluvoxamine is an alternative treatment. After a 3-week period of evaluation, patients meeting study entry criteria are randomized to receive either fluvoxamine or placebo for 8 weeks. After this double-blind phase, patients can enter a 4-month open-label extension.
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 6 Years/17 Years
Genders: Both
Protocol Entry Criteria: - Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LaurenceGreenhill,  Principal Investigator, 


Additional Information:
Study ID Numbers:
  MH60005;  MH60016
Study Start Date: October 1996
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000389

Other Separation Anxiety Studies:
1. Treatment for Anxiety in Children

2. Treatment of Youth with ADHD and Anxiety

3. Treatment of Social Phobia

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