Treatment for Anxiety in Children

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Obsessive-Compulsive Disorder; Separation Anxiety; Social Phobia; Generalized Anxiety Disorder; Anxiety Disorders

Treatments: Drug: Fluvoxamine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000389

N01 MH60016

N01 MH60005

DSIR CT

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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