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Fluvoxamine for the Treatment of Anxiety Disorders in Children and Adolescents
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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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“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]
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“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]
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“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]
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“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].”
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“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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“Another study found that 76% of participants treated with fluvoxamine were classified as 'much improved,' compared to 29% in the placebo group [59].”
From The risks versus the benefits of pharmacological intervention in social anxiety disorder in children (2025) · cites this paper as [59]
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“The participants allocated to the fluvoxamine experimental group benefited from a significant decrease in anxiety symptoms compared to the participants allocated to the placebo group.”
From The risks versus the benefits of pharmacological intervention in social anxiety disorder in children (2025) · cites this paper as [40]
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“The most prevalent observed side-effects were headache, abdominal discomfort, increased motor activity and difficulty falling asleep.”
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Metadata
- 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
- 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
- bronze
- doi.org
- 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 (medical) › 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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