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Treatment for Anxiety in Children

Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000389
Enrollment
Unknown
Registered
1999-11-03
Start date
1996-10-31
Completion date
1999-11-30
Last updated
2007-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, Separation Anxiety, Social Phobia

Keywords

Adolescence, Anxiety Disorders, Child, Female, Fluvoxamine, Human, Male, Serotonin Uptake Inhibitors, Anxiety Disorders -- *drug therapy, Fluvoxamine -- *therapeutic use, Serotonin Uptake Inhibitors -- *therapeutic use

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.

Interventions

DRUGFluvoxamine

Sponsors

National Institute of Mental Health (NIMH)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026