NCT00000389

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1996

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1999

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
Last Updated

June 14, 2007

Status Verified

November 1, 2005

First QC Date

November 2, 1999

Last Update Submit

June 13, 2007

Conditions

Obsessive-Compulsive DisorderAnxiety DisordersGeneralized Anxiety DisorderSocial PhobiaSeparation Anxiety

Keywords

AdolescenceAnxiety DisordersChildFemaleFluvoxamineHumanMaleSerotonin Uptake InhibitorsAnxiety Disorders -- *drug therapyFluvoxamine -- *therapeutic useSerotonin Uptake Inhibitors -- *therapeutic use

Interventions

FluvoxamineDRUG

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
\- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 11323729BACKGROUND

  • 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.

    PMID: 11320394BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAnxiety DisordersGeneralized Anxiety DisorderPhobia, SocialAnxiety, Separation

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Mental DisordersPhobic DisordersNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

OximesHydroxylaminesAminesOrganic Chemicals

Study Officials

  • Laurence Greenhill, MD

    PRINCIPAL INVESTIGATOR

  • Mark Riddle, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

October 1, 1996

Study Completion

November 1, 1999

Last Updated

June 14, 2007

Record last verified: 2005-11