Fluvoxamine for the treatment of anxiety disorders in children and adolescents

Daniel S. Pine, John T. Walkup, Michael J. Labellarte, Mark A. Riddle, Laurence Greenhill, Rachel Klein, Mark Davies, Michael Sweeney, Howard Abikoff, Sabine Hack, Brian Klee, James McCracken, Lindsey Bergman, John Piacentini, John March, Scott Compton, James Robinson, Thomas O'Hara, Sherryl Baker, Benedetto VitielloLouise Ritz, Margaret Roper

Research output: Contribution to journalArticle

Abstract

Background: Drugs that selectively inhibit serotonin reuptake are effective treatments for adults with mood and anxiety disorders, but limited data are available on the safety and efficacy of serotonin-reuptake inhibitors in children with anxiety disorders. Methods: We studied 128 children who were 6 to 17 years of age; who met the criteria for social phobia, separation anxiety disorder, or generalized anxiety disorder; and who had received psychological treatment for three weeks without improvement. The children were randomly assigned to receive fluvoxamine (at a maximum of 300 mg per day) or placebo for eight weeks and were evaluated with rating scales designed to assess the degree of anxiety and impairment. Results: Children in the fluvoxamine group had a mean (±SD) decrease of 9.7±6.9 points in symp toms of anxiety on the Pediatric Anxiety Rating Scale (range of possible scores, 0 to 25, with higher scores indicating greater anxiety), as compared with a decrease of 3.1±4.8 points among children in the placebo group (P<0.001). On the Clinical Global Impressions-Improvement scale, 48 of 63 children in the fluvoxamine group (76 percent) had a response to the treatment, as indicated by a score of less than 4, as compared with 19 of 65 children in the placebo group (29 percent, P±0.001). Five children in the fluvoxamine group (8 percent) discontinued treatment because of adverse events, as compared with one child in the placebo group (2 percent). Conclusions: Fluvoxamine is an effective treatment for children and adolescents with social phobia, separation anxiety disorder, or generalized anxiety disorder.

Original languageEnglish (US)
Pages (from-to)1279-1285
Number of pages7
JournalNew England Journal of Medicine
Volume344
Issue number17
DOIs
StatePublished - Apr 26 2001

ASJC Scopus subject areas

  • Medicine(all)

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    Pine, D. S., Walkup, J. T., Labellarte, M. J., Riddle, M. A., Greenhill, L., Klein, R., Davies, M., Sweeney, M., Abikoff, H., Hack, S., Klee, B., McCracken, J., Bergman, L., Piacentini, J., March, J., Compton, S., Robinson, J., O'Hara, T., Baker, S., ... Roper, M. (2001). Fluvoxamine for the treatment of anxiety disorders in children and adolescents. New England Journal of Medicine, 344(17), 1279-1285. https://doi.org/10.1056/NEJM200104263441703