Fluvoxamine for the Treatment of Anxiety Disorders in Children and Adolescents
John T. Walkup, M.D., Michael J. Labellarte, M.D., Mark A. Riddle, M.D., Daniel S. Pine, M.D., Laurence Greenhill, M.D., Rachel Klein, Ph.D., Mark Davies, M.P.H., Michael Sweeney, Ph.D., Howard Abikoff, Ph.D., Sabine Hack, M.D., Brian Klee, M.D., James McCracken, M.D., Lindsey Bergman, Ph.D., John Piacentini, Ph.D., John March, M.D., M.P.H., Scott Compton, Ph.D., James Robinson, M.Ed., Thomas O'Hara, M.B.A., Sherryl Baker, Ph.D., Benedetto Vitiello, M.D., Louise Ritz, M.B.A., Margaret Roper, M.P.H., for the Research Unit on Pediatric Psychopharmacology Anxiety Study Group
Background Drugs that selectively inhibit serotonin reuptakeare effective treatments for adults with mood and anxiety disorders,but limited data are available on the safety and efficacy ofserotonin-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 psychologicaltreatment for three weeks without improvement. The childrenwere randomly assigned to receive fluvoxamine (at a maximumof 300 mg per day) or placebo for eight weeks and were evaluatedwith rating scales designed to assess the degree of anxietyand impairment.
Results Children in the fluvoxamine group had a mean (±SD)decrease of 9.7±6.9 points in symptoms of anxiety onthe Pediatric Anxiety Rating Scale (range of possible scores,0 to 25, with higher scores indicating greater anxiety), ascompared with a decrease of 3.1±4.8 points among childrenin the placebo group (P<0.001). On the Clinical Global ImpressionsImprovementscale, 48 of 63 children in the fluvoxamine group (76 percent)had a response to the treatment, as indicated by a score ofless than 4, as compared with 19 of 65 children in the placebogroup (29 percent, P<0.001). Five children in the fluvoxaminegroup (8 percent) discontinued treatment because of adverseevents, as compared with one child in the placebo group (2 percent).
Conclusions Fluvoxamine is an effective treatment for childrenand adolescents with social phobia, separation anxiety disorder,or generalized anxiety disorder.
Source Information
Dr. Pine accepts responsibility for the overall content and integrity of the manuscript.
Address reprint requests to Dr. Daniel S. Pine at the Program on Mood and Anxiety Disorders, National Institute of Mental HealthIntramural Research Program, Bldg. 10, Rm. 4N-222 (MSC-1381), Bethesda, MD 20892-1381, or at daniel.pine{at}nih.gov.
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