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Cited by 590Anxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesChild and Adolescent Psychosocial and Emotional DevelopmentTreatment of Major Depression

Fluvoxamine for the Treatment of Anxiety Disorders in Children and Adolescents

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Walkup, John T., Labellarte, Michael J., Riddle, Mark A., Pine, Daniel S., Greenhill, Laurence, Klein, Rachel, Davies, Mark, Sweeney, Michael +14 more·2001·New England Journal of Medicine
DOI 10.1056/nejm200104263441703
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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 symptoms 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) responded 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.

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  • Paroxetine use may have side effects including insomnia, decreased appetite, vomiting, withdrawal, agitation, emotional liability and four patients described suicide ideations without attempting to consummate.

    “Despite its positive effects, the use of paroxetine may have caused as side-effects insomnia, decreased appetite, vomiting, withdrawal, agitation, emotional liability and four patients described suicide ideations without attempting to consummate.”

    From The risks versus the benefits of pharmacological intervention in social anxiety disorder in children (2025) · cites this paper as [41]

    The Methods passage (page not provided) says children were assigned to fluvoxamine or placebo, not paroxetine. Table 3 lists difficulty falling asleep, vomiting, and decreased appetite in those trial groups, but does not establish these as paroxetine side effects; the cited paper also does not report four patients developing suicidal ideation. (LLM, conf=0.90)

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  • Fluvoxamine is considered effective and well tolerated in the long-term treatment of anxiety disorders with children and adolescents.

    “In contrast, fluvoxamine is considered effective and well tolerated in the long-term treatment of anxiety disorders with children and adolescents [40].”

    From The risks versus the benefits of pharmacological intervention in social anxiety disorder in children (2025) · cites this paper as [40]

    The Discussion reports that fluvoxamine was effective and generally well tolerated in children with the specified anxiety disorders. However, the Patients section describes only eight weeks of fluvoxamine or placebo treatment, so this study does not establish effectiveness or tolerability in long-term treatment. (LLM, conf=0.90)

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  • In the fluvoxamine RCT, drop-out was higher in the fluvoxamine condition (n = 5) than the placebo group (n = 2) due to side effects.

    “Moreover, the fluvoxamine condition drop-out was higher (n = 5) than the placebo group (n = 2) due to sideeffects.”

    From The risks versus the benefits of pharmacological intervention in social anxiety disorder in children (2025) · cites this paper as [40]

    The ‘Premature Discontinuation of Treatment and Worsening of Anxiety’ section reports five fluvoxamine withdrawals due to adverse events, but only one placebo withdrawal due to irritability and insomnia—not two. The Discussion also states the adverse-event discontinuation counts were five versus one. (LLM, conf=0.90)

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  • Studies examining efficacy of fluvoxamine and sertraline have reported a significant reduction in severity of anxiety symptoms after only 12 weeks.

    “For example, studies examining the efficacy of fluvoxamine and sertraline have reported a significant reduction in the severity of the anxiety symptoms after only 12 weeks [37,59].”

    From The risks versus the benefits of pharmacological intervention in social anxiety disorder in children (2025) · cites this paper as [59]

    The Efficacy section reports significantly greater reductions in anxiety symptoms with fluvoxamine than with placebo. But the Methods and Discussion say the trial lasted eight weeks, not 12. This source supports the fluvoxamine finding, but not the stated 12-week timing. (LLM, conf=0.87)

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  • Additional research suggests combining psychotherapy with pharmacotherapy yields better outcomes than either approach alone, as psychotherapy can teach skills in managing fear-inducing social situations while pharmacotherapy alleviates symptoms facilitating greater participation in behavioral interventions.

    “Additional research suggests that combining psychotherapy with pharmacotherapy yields better outcomes than either approach alone, as psychotherapy can teach valuable skills in managing fear-inducing social situations while pharmacotherapy alleviates symptoms facilitating greater participation in behavioral interventions [60,61].”

    From The risks versus the benefits of pharmacological intervention in social anxiety disorder in children (2025) · cites this paper as [60]

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Cites

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Research works printed but not linked: 5

  1. description, acceptability, prevalence rates, and performance in the MECA Study: Methods for the Epidemiology of Child and Adolescent Mental Disorders Study. J Am Acad Child Adolesc Psychiatry 1996;35:865-77.
  2. Stein MB. Medication treatments for panic disorder and social phobia. Depress Anxiety 1998;7:134-8.
  3. Walkup J, Davies M. The Pediatric Anxiety Rating Scale (PARS): a re- liability study. In: Scientific proceedings of the 46th Annual Meeting of the American Academy of Child and Adolescent Psychiatry, Chicago, October 19-24, 1999:NR78. abstract.
  4. Wagner KD, Birmaher B, Carlson G, et al. Multi-center trial of parox- etine and imipramine in the treatment of adolescent depression. In: Scien- tific proceedings of the 45th Annual Meeting of the American Academy of Child and Adolescent Psychiatry, Anaheim, Calif., October 27-November 1, 1998:S12D. abstract.
  5. Guyatt GH, Sackett DL, Cook DJ. Users' guides to the medical liter- ature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? JAMA 1993;270:2598-601.

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Authors
Walkup, J. T., Labellarte, M. J., Riddle, M. A., Pine, D. S., 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., Vitiello, B., Ritz, L., & Roper, M.
Affiliations
  • New York State Psychiatric Institute (US)
  • University of California, Los Angeles (US)
  • Duke University (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2001-04-26
Volume
344
Issue
17
Pages
1279-1285
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejm200104263441703
OpenAlex
W2330595721
Cited by
588
References
42
Citations by year
2026: 5 · 2025: 7 · 2024: 18 · 2023: 7 · 2022: 12 · 2021: 14 · 2020: 12 · 2019: 15 · 2018: 10 · 2017: 18 · 2016: 17 · 2015: 19 · 2014: 20 · 2013: 23 · 2012: 23
FWCI
73.53
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Brown University
  • Johns Hopkins University
  • York University
  • National Institutes of Health (n01mh060005-010, n01mh060016-007, n01mh070010-001)
  • University of Illinois at Urbana-Champaign
  • National Institute of Mental Health (N01 MH 70010, N01 MH60005, N01MH60016)
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
Keywords
fluvoxamine, selective serotonin reuptake inhibitors, childhood anxiety disorders, social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, children and adolescents, drug safety and efficacy, adverse events
MeSH terms
Adolescent, Anxiety Disorders, Anxiety, Separation, Child, Female, Humans, Male, Phobic Disorders, Psychotherapy, Anti-Anxiety Agents, Fluvoxamine, Selective Serotonin Reuptake Inhibitors

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