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12 week randomised, double blind, placebo controlled trial.
12 sites in the US.
189 patients who were 6–17 years of age and met the DSM-III-R diagnostic criteria for OCD, had a score of ≥7 on the National Institute of Mental Health Global Obsessive Compulsive Rating Scale (NIMH GOCS) (moderate impairment in global functioning), and a score of ≤17 on the Hamilton Depression Scale (no substantial depression). Follow up was 83%.
Patients were allocated to 25 mg/day of sertraline (50 mg/d for adolescents) (n=92) or matching placebo (n=95). Dosages were titrated upward by 50 mg/week to a maximum dosage of 200 mg/day during the first 4 weeks of treatment.
Main outcome measures
Mean change from baseline on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), the National Institute of Mental Health Clinical Global Impression of Severity of Illness (NIMH CGI-S) and Improvement (NIMH CGI-I) scales, and the NIMH GOCS. Responders were defined as having a >25% decrease in OCD symptoms as measured on the CY-BOCS and much or very much improved on the NIMH CGI scales.
Using intention to treat analysis, patients who received sertraline showed greater improvement than patients who received placebo on the CY-BOCS (p=0.005), the NIMH GOCS (p=0.02), and the NIMH CGI-I scale (p=0.002), and a trend toward improvement on the NIMH CGI-S scale (p=0.09) (table 1⇓). More patients who received sertraline achieved a 25% decrease in CY-BOCS score (p=0.03) and a rating of very much or much improved on the NIMH CGI-I scales (p=0.02) (table 2⇓).
Children and adolescents with obsessive compulsive disorder who received sertraline showed improvement in 3 of 4 main dependent measures.
This well designed multicentre study by March et al provides further support for the therapeutic efficacy of a selective serotonin reuptake inhibitor (SSRI) (ie, sertraline) in the treatment of children and adolescents who have OCD. Given these and other study results, the clinician treating OCD in young people should clearly prescribe an SSRI as the initial pharmacological intervention. Taken as a group, these compounds are safe, efficacious, and have few side effects.
These data, however, raise further questions. One issue of clinical importance not addressed by the study is the effect of SSRIs on sexual functioning. The high prevalence of delayed orgasm is well known from studies of adults, but this and other potential adverse sexual effects have not been sufficiently investigated in youths. Indeed, little is known about sexual functioning in teens with OCD, and this area should be addressed in future investigations.
Long term use, the effect of medication discontinuation on symptom expression, the effect and role of concurrent psychotherapies (such as cognitive behaviour therapy), and the effect of SSRI treatment on such broader issues as academic functioning, peer and intimate relationships, family functioning, quality of life, and costs needs to be critically evaluated.
It is heartening to observe the publication of rigorous, well controlled pharmacological trials in the acute treatment of OCD in young people. Given the evidence available to date and the needs of the field, future investigations should not involve “me too” studies of different SSRIs in acute treatment but should address the clinically meaningful issues outlined above.
Source of funding: Pfizer Inc, New York, NY.
For correspondence: Dr J S March, Pediatric Psychiatry, Duke University Medical Center, Box 3527, Durham, NC 27710, USA. Fax +1 919 684 8804.
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