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Sertraline reduced patient dropout rates and acute exacerbation of symptoms in obsessive compulsive disorder
  1. G Mustafa Soomro, MBBS, MRCPsych, MSc
  1. St George’s Hospital Medical School, London, UK

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QUESTION: In outpatients with obsessive compulsive disorder (OCD) who have achieved a sustained response during 52 weeks of treatment with sertraline, is additional treatment with sertraline effective for preventing relapse, dropout from the study, or acute exacerbations of OCD symptoms?

Design

28 week randomised {allocation concealed*}, blinded (patients and healthcare providers)*, controlled trial.

Setting

21 sites in the US.

Patients

223 outpatients who were >18 years of age (mean age 39 y, 56% men), met DSM-III-R criteria for OCD, and had achieved a sustained response during 52 weeks of treatment with sertraline. Exclusion criteria included a score of ≥17 on the Hamilton Depression Rating Scale and a current or verified past diagnosis of schizophrenia, delusional disorder, or other psychosis.

Intervention

Patients were allocated to sertraline (50–200 mg/d) (n=109) or placebo (n=114).

Main outcome measures

Dropout from the study because of relapse or insufficient response, acute exacerbation of OCD symptoms, relapse, and quality of life. Relapse was defined according to 3 criteria: increase in Yale Brown Obsessive Compulsive Scale (YBOCS) score of ≥5, total YBOCS score of ≥20, and ≥1 point increase on the Clinical Global Impression (CGI) improvement scale during 3 consecutive visits at 2 week intervals. Acute exacerbation of OCD was defined as an increase in YBOCS score of ≥5 points to ≥20 or an increase in score of ≥2 points on the CGI improvement scale; and response was defined as ≥25% decrease in total YBOCS scores from baseline level and CGI improvement scale score ≤3.

Main results

The rates of dropout from the study because of relapse or insufficient clinical response and acute exacerbation of OCD symptoms were lower in the sertraline than in the placebo group (table). Time from randomisation to dropout from the study because of relapse or insufficient clinical response and time from randomisation to acute exacerbation of OCD symptoms were greater in the sertraline than in the placebo group (p values <0.001). Improvement in quality of life was greater in the sertraline than the placebo group (p=0.007). The groups did not differ for relapse or adverse effects.

Sertraline v placebo in obsessive compulsive disorder after a sustained response to 52 weeks of sertraline treatment‡

Conclusion

In outpatients with obsessive compulsive disorder (OCD) who have achieved a sustained response during 52 weeks of treatment with sertraline, additional treatment with sertraline was effective for reducing dropout rates because of relapse or insufficient response and exacerbation of OCD symptoms.

COMMENTARY

Limited evidence exists regarding the optimum duration of drug treatment for OCD.1 The 2 main issues to consider include the duration of treatment for maximum improvement and the need and duration for maintenance treatment.

The duration of most trials assessing efficacy has been up to 12 weeks.2 With respect to maintenance treatment, the trial by Koran et al found no difference in the relapse rate of OCD between sertraline and placebo (2.8% v 4.0%, p=0.34), a result consistent with the findings in a previous trial that compared fluoxetine with placebo (21% v 32%, p=0.137)3 and conflicting with those in another trial that compared paroxetine with placebo (38% v 59%).4 The striking difference in the overall relapse rates between this trial and the previous studies may be attributed to the stringent definition of relapse used in this study. However, this trial showed that discontinuation of sertraline resulted in a higher rate of exacerbation of symptoms (defined less stringently than the relapse) and higher rate of dropout due to relapse or insufficient response (insufficient response was not objectively defined). Because relapse rates were similar between the groups, the difference in dropout rates was mainly due to insufficient clinical response. However, the average time period to the emergence of these differences was not given, and dropout rates for other reasons were not analysed although the data were reported.

Overall, limited evidence suggests that maintenance drug treatment after a sustained response (of 20 wks to 1 year) does not reduce relapse rates, but this trial provides limited evidence that maintenance treatment with sertraline for 28 weeks reduces the rate of acute exacerbation of symptoms and the dropout rate because of insufficient response.

References

View Abstract

Footnotes

  • For correspondence: Dr L M Koran, Stanford University, Stanford, CA, USA. lkoran{at}stanford.edu

  • Source of funding: Pfizer, Inc.

  • * See glossary.

  • Information provided by author.

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