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
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
- 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
NCT ID
NCT00000389
First Posted
November 2, 1999
Last Updated
June 13, 2007
Sponsor
National Institute of Mental Health (NIMH)
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
background
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Treatment for Anxiety in Children
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