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PAPERS: K. C. M. WILSON, P. G. MOTTRAM, L. ASHWORTH, and M. T. ABOU-SALEH Older community residents with depression: long-term treatment with sertraline: Randomised, double-blind, placebo-controlled study The British Journal of Psychiatry 2003; 182: 492-497 [Abstract] [Full text] [PDF]

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Insignificant protection against recurrent depression with sertraline- how valid is the conclusion?

Sudhir Kumar   (5 June 2003)

Insignificant protection against recurrent depression with sertraline-how valid is the conclusion.

Kenneth C Wilson   (11 June 2003)

Insignificant protection against recurrent depression with sertraline- how valid is the conclusion? 5 June 2003
Sudhir Kumar, Consultant Neurologist Neurology Unit, Christian Medical College Hospital, Vellore, Tamilnadu, India-632004 Send letter to journal: Re: Insignificant protection against recurrent depression with sertraline- how valid is the conclusion? drsudhirkumar{at}yahoo.com Sudhir Kumar	Sir, I read with interest the recent article by Wilson KCM et al Wilson, 2003). On the basis of a randomized, double blind, placebo-controlled trial, they conclude that sertraline is not effective in preventing recurrent episodes of depression. However, I would like to make certain observations. Firstly, looking at Table 2, we find that the number of patients remaining in the study at 100 weeks of follow up is 15 in the sertraline group and 12 in the placebo group. These numbers are too small to draw any major conclusions. Also, looking at the same table, we find that at the end of four weeks, there were six cases of recurrent depression in the placebo group as compared to only two in the sertraline group. This means that sertraline group had significantly less recurrent cases of depression in the first four weeks of prophylactic therapy. Secondly, I would like to make an observation about statistical significance versus clinical significance. Again looking at Table 2, we find that the number of cumulative recurrences were less in the sertraline group as compared to placebo group at all points of the maintenance phase of two years. Even though these numbers have not assumed statistical significance, they are clinically significant. This opinion is based on two reasons- firstly, for a physician; prevention of even one case of recurrence is important and satisfying. Secondly, talking from a community and financial perspective, sertraline prophylaxis has been found to be more cost-effective than treating each new episode of depression with dothiepin (Hatziandreu et al, 1994). If the authors of the current paper had included an analysis of treatment costs involved (including the cost of treating episodes of recurrent depression) in both the groups, it would have made an interesting reading. Thirdly, as the authors have pointed out, failure to increase the dose of sertraline at the earliest signs of recurrence has contributed to a higher number of recurrences observed in this study. There should have been a provision to increase the dose of sertraline as and when the clinical situation demanded it. After all, a significant number of patients do require a daily dose in excess of 50 mg of sertraline (Suri et al, 2000), a dose that was used to treat almost three-quarters of patients in this study. In conclusion, the data presented in this study is insufficient to suggest making any changes in the current practice of prescribing sertraline for treatment and prophylaxis of depression in older people. References 1. Hatziandreu EJ, Brown RE, Revicki DA, et al (1994). Cost utility of maintenance treatment of recurrent depression with sertraline versus episodic treatment with dothiepin. Pharmacoeconomics, 5, 249-68. 2. Suri RA, Altshuler LL, Rasgon NL, et al (2000). Efficacy and response time to sertraline versus fluoxetine in the treatment of unipolar major depressive disorder. Journal of Clinical Psychiatry, 61, 942-6 3. Wilson KCM, Mottram PG, Ashworth L, et al (2003). Older community residents with depression: long-term treatment with sertraline. British Journal of Psychiatry, 182, 492-97.
Insignificant protection against recurrent depression with sertraline-how valid is the conclusion. 11 June 2003
Kenneth C Wilson, Professor Univeristy of Liverpool Send letter to journal: Re: Insignificant protection against recurrent depression with sertraline-how valid is the conclusion. kw500505{at}liverpool.ac.uk Kenneth C Wilson	Sir, In response to Dr Kumar's comments there are some important issues that need addressing. Firstly Dr Kumar introduces his letter in saying that we conclude that sertraline is not effective in preventing recurrent episodes of depression. This is not the case. We only stated that there is no evidence that sertraline has a prohylactic efficacy when used at the dose that acheived remission. Secondly, we agree that if we had conducted an end point analysis on the 27 subjects that completed the 100 week follow up then the study would have been relatively meaningless. We conducted a survival analysis on 113 subjects. This is a well founded and recognised method of analysis of this type of study. Thirdly, we concur with Dr Kumar in that the prophylactic management of recurrent depression is critical. We do not advocate treating each episode as a new episode when prophylactic management is indicated. However, we do make the point that preventative techniques should be based on evidence of efficacy and effectiveness. Dr Kumar suggests that the we should have adopted a protocol that enabled increase in dose 'when the clinical situation demanded it'; persumably when we thought a patient was experiencing the early stages of a recurrence. This misses the point of the paper. Our study (which is of a similar or greater power to equivalent studies in this field) shows that the dose of sertraline required to achieve remission does not have prophylactic efficacy. This is important, as what evidence there is suggests that therapeutic doses of dothiepin (OADIG 1993), nortriptyline (Reynolds 1999) and citalopram (Klysner 2002) do have prohphylactic efficacy. The implications for guidelines concerning the long term management of older people with depression are self-evident. Dr Kumar has failed to present arguments that undermine our conclusions. There is no evidence that the dose of sertraline required to achieve remission has prohylactic efficacy. The 8.4% reduction in risk of recurrence (over 100 weeks) that it offers is unlikely to instil clinical confidence in prohylactic efficacy when evidence indicates that other drugs for which the dose does not need to be changed are available. References OADIG (1993) How long should the elderly take antidepresants? A double blind placebo-controlled study of continuation/prophylaxis therapy with dothiepin. Britsh Journal of Psychiatry. 162,175-182 Klysner R, Bent-Hansen J, Hansen H et al (2002) Efficacy of citalopram in the prevention of recurrent depression in elderly patients: placebo-controlled study of maintenance therapy. British Journal of Psychiatry. 181,29-35. Reynolds CF, Frank E, Perel JM et al. (1999) Nortriptyline and interpersonal psychotherapy as maintenance therapies for recurrent major depression. A randomised controlled trial in patients older than 59 years JAMA 281, 39-45. Professor Wilson.