What was the main issue or questions being addressed?
The New England Journal of Medicine 1 recently published a study showing that fluvoxamine, a Selective Serotonin Reuptake inhibitor (SSRI), is a safe and effective treatment for children and adolescents with anxiety disorders. A good number of studies show that SSRI's effectively treat adults' anxiety, but there is very limited scientific information about treating children's anxiety with SSRI's.
What are the main findings or conclusions?
The Research Units in Pediatric Psychpharmacology (RUPP) Anxiety Study Group
designed the study with the help and funding of the National Institutes of Mental Health. The study was intended to answer the question: does fluvoxamine help children and adolescents who are suffering with anxiety? The study took place at five different medical centers including New York University.
128 Children, ages 6 to 17, participated in the medication study only after their anxiety did not improve following three weekly visits with the study doctor. All the children had at least one and possibly two or three of the following anxiety disorders: social phobia, separation anxiety disorder and generalized anxiety disorder. The children were assigned by chance to receive either fluvoxamine or placebo (a non-medication dummy pill) for 8 weeks. Both Doctors and families did not know if a particular child was taking fluvoxamine or placebo during that time. For eight weeks, the doctor saw the children and their parents weekly to see if the children's anxiety was improving and to see if the children were having any side effects from the medication. The children, their parents and the doctor all rated how the child was doing and if their anxiety symptoms were still getting in their way. Improvement was based on ratings of 50 symptoms that characterize the three different anxiety disorders. At the end of the eight weeks, 76% of the children taking fluvoxamine were doing significantly better, while only 29% of the children taking placebo were doing better. Although the children taking fluvoxamine had more stomachaches than the children taking placebo, most of the children tolerated the fluvoxamine well,
This study is the first large-scale controlled study that demonstrates that fluvoxamine can treat social phobia, generalized anxiety disorder or separation anxiety disorder in children. The results of the study were dramatic and the children tolerated the medication well.
Are there any practical implications?
Practically, this means that fluvoxamine and perhaps all the SSRI's can be considered as treatment options for children who are suffering with these specific anxiety disorders. The study doesn't give us any information about whether behavioral treatments (which have also been proven to help children with anxiety disorders) or medication, or some combination of both is the best treatment. Additional research is needed to address this question. Parents of anxious children should consult with a doctor about what is the best treatment approach for their particular child.
About the Author
Sabine Hack, M.D. is Assistant Professor of Clinical Psychiatry, NYU School of Medicine.
1 The Research Unit on Pediatric Psychopharmacology Anxiety Study Group (2001) Fluvoxamine for the treatment of anxiety disorder in children and adolescents. New England Journal of Medicine, 344, (17), 1279-1285.