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Treatment for Anxiety in Children

NCT00000389 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2007-06-14

No results posted yet for this study

Summary

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).

Conditions

  • Obsessive-Compulsive Disorder
  • Anxiety Disorders
  • Generalized Anxiety Disorder
  • Social Phobia
  • Separation Anxiety

Interventions

DRUG

Fluvoxamine

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Laurence Greenhill, MD

  • Mark Riddle, MD

Study Design

Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-10-31
Completion
1999-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000389 on ClinicalTrials.gov