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QUESTION: In children with social phobia, separation anxiety disorder, or generalised anxiety disorder, how effective is fluvoxamine, compared with placebo, in reducing anxiety?
5 medical centres in the US.
128 children who were 6–17 years of age (74% 6–12 y, 51% boys) and met the DSM-IV criteria for social phobia, separation anxiety disorder, or generalised disorder. Other inclusion criteria were clinically important symptoms of anxiety according to the Pediatric Anxiety Rating Scale (PARS) and clinically important impairment according to the Children's Global Assessment Scale (CGAS). Exclusion criteria were current treatment with a psychoactive substance, major depression, Tourette's syndrome, obsessive compulsive disorder, post-traumatic stress disorder, conduct disorder, panic disorder, mania, psychosis, pervasive developmental disorder, suicidal ideation, intelligence quotient <70, previous treatment with a selective serotonin reuptake inhibitor, or attention deficit disorder requiring drug treatment. 104 children (81%) completed the study.
Patients were allocated to fluvoxamine, maximum 300 mg/day in adolescents and 250 mg/day in children (n=63) or placebo (n=65).
Main outcome measures
Change in score on the PARS (range 0–25; 10=mild 20=high levels of anxiety) and Clinical Global Impressions-Improvement scale (CGI-I) (8 point scale; 3=improved, 2=much improved, and 1=symptom free).
Analysis was by intention to treat. Patients who received fluvoxamine showed greater improvement on the PARS than patients who received placebo. Differences between the groups were detectable at 3 weeks and increased through week 6 with no appreciable change to week 8 (p<0.001) (table). Fluvoxamine group patients also showed greater improvement than placebo group patients on the CGI-I scale (p<0.001) (table). Abdominal discomfort was the only significant adverse effect that occurred more frequently in the fluvoxamine group (49% v 28%, p=0.02).
In children with social phobia, separation anxiety disorder, or generalized anxiety disorder, fluvoxamine reduced anxiety and was well tolerated.
Treatment research specific to the young is needed because experience has shown that results from treatment studies in adults cannot necessarily be generalised to children. The efficacy of cognitive behaviour treatment (CBT) for anxiety disorders in children and adolescents has been shown in randomised controlled trials.1 In contrast, pharmacotherapy studies involving tricyclic antidepressant drugs and benzodiazepines have been equivocal.2
In the study by the Research Unit on Pediatric Psychopharmacology Anxiety Study Group, fluvoxamine was superior to placebo in reducing anxiety symptoms in children aged 6–17 years. To maintain perspective, the mean anxiety scores for the active treatment group remained within the range associated with mild but clinically significant symptoms. Participants were deemed “responders” if they had shown improvement, even though symptoms may not have remitted. The integrity of the blinding was not reported. Treatment status may have been apparent to clinician raters and contributed to rater bias because of the presence of abdominal discomfort and motor restlessness in the treated group. Self report measures used to determine outcome were not reported. It is conceivable, therefore, that although clinicians perceived improvement in the treated group, the children themselves did not feel much better. This can be important when considering motivation to persist with treatment.
As acknowledged by the investigators, the study does not tell us whether fluvoxamine is superior or inferior to CBT. A comparative trial is required to resolve this issue. A conservative interpretation of the data is that treatment with fluvoxamine reduces anxiety symptoms in children, but does not necessarily result in remission. More robust evidence exists to support the use of CBT for anxiety disorders in children and adolescents.
↵† Information provided by author.
Sources of funding: National Institute of Mental Health; Research Foundation for Mental Hygiene; Solvay Pharmaceuticals; National Center for Research Resources – National Institutes of Health General Clinical Research Center.
For correspondence:Dr D S Pine, Program on Mood and Anxiety Disorders, National Institute of Mental Health-Intramural Research Program, Building 10, Room 4N-222 (MSC-1381), Bethesda, MD 20892-1381, USA. Fax +1 301 443 4279.
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