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Treatment for Anxiety in Children

Primary Purpose

Obsessive-Compulsive Disorder, Anxiety Disorders, Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fluvoxamine
Sponsored by
National Institute of Mental Health (NIMH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Adolescence, Anxiety Disorders, Child, Female, Fluvoxamine, Human, Male, Serotonin Uptake Inhibitors, Anxiety Disorders -- *drug therapy, Fluvoxamine -- *therapeutic use, Serotonin Uptake Inhibitors -- *therapeutic use

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    June 13, 2007
    Sponsor
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000389
    Brief Title
    Treatment for Anxiety in Children
    Official Title
    Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 1999 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Mental Health (NIMH)

    4. Oversight

    5. Study Description

    Brief 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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder, Anxiety Disorders, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety
    Keywords
    Adolescence, Anxiety Disorders, Child, Female, Fluvoxamine, Human, Male, Serotonin Uptake Inhibitors, Anxiety Disorders -- *drug therapy, Fluvoxamine -- *therapeutic use, Serotonin Uptake Inhibitors -- *therapeutic use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    Double

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Fluvoxamine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    - Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laurence Greenhill, MD
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mark Riddle, MD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11323729
    Citation
    Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85. doi: 10.1056/NEJM200104263441703.
    Results Reference
    background
    PubMed Identifier
    11320394
    Citation
    Coyle JT. Drug treatment of anxiety disorders in children. N Engl J Med. 2001 Apr 26;344(17):1326-7. doi: 10.1056/NEJM200104263441711. No abstract available.
    Results Reference
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    Treatment for Anxiety in Children

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