NCT00000381

Brief Summary

The purpose of this study is to see if it is safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder (GAD). Anxiety disorders are one of the most common psychiatric disorders in children and adolescents, and can cause disturbances in the child's school, social, and family lives. Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to continue into adulthood. There is very little information on anxiety medications for children. Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug levels in the blood. The study will last for 12 weeks. A child is eligible for this study if he/she: Is 8 to 17 years old and has anxiety disorder. A child will not be eligible for this study if he/she: Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses alcohol or drugs.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1997

Longer than P75 for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1997

Completed
2.4 years 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
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

January 8, 2014

Status Verified

December 1, 2005

Enrollment Period

5.9 years

First QC Date

November 2, 1999

Last Update Submit

January 7, 2014

Conditions

Anxiety Disorders

Keywords

AdolescenceAnxiety DisordersChildFemaleFluoxetineMalePlacebosSerotonin Uptake InhibitorsAnxiety Disorders -- *drug therapyFluoxetine -- *therapeutic useSerotonin Uptake Inhibitors -- *therapeutic use

Interventions

FluoxetineDRUG

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Patients must have:
  • Generalized anxiety disorder.

You may not qualify if:

  • Excluded:
  • Patients with current major depression, as well as patients with panic and obsessive-compulsive disorder.
  • Excluded:
  • Current substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Birmaher B, Axelson DA, Monk K, Kalas C, Clark DB, Ehmann M, Bridge J, Heo J, Brent DA. Fluoxetine for the treatment of childhood anxiety disorders. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):415-23. doi: 10.1097/01.CHI.0000037049.04952.9F.

    PMID: 12649628RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Boris Birmaher, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

June 1, 1997

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

January 8, 2014

Record last verified: 2005-12