Treatment for Anxiety in Children

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).

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Anxiety, Separation Generalized Anxiety Disorder Mental Disorders Neurodevelopmental Disorders Phobia, Social Phobic Disorders Separation Anxiety Social Phobia

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluvoxamine

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health (NIMH)

Nih

Registry information

Official study title

Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study

Important dates

Study start: 1996
Study completion: 1999
First posted: Nov 3, 1999
Registry last updated: Jun 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed