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QUESTION: What are the effects of long term sertraline or placebo maintenance treatment on measures of psychosocial function in chronic depression?
Randomised controlled trial. Participants, clinicians and outcome assessors were blind to treatment allocation.
12 US academic medical centres; September 1993– November 1996.
161 adults with chronic depression in remission or with satisfactory response after 12 weeks of acute phase treatment with sertraline and a 16 week continuation phase. 53% had double depression; 47% had chronic major depression; 66% women; mean age 42 years.
At the end of continuation phase treatment, responders to sertraline received 18 months of maintenance therapy with either sertraline or placebo.
Main outcome measures
Psychosocial outcomes were measured using a range of scales including the Social Adjustment Scale – Self Report (SAS-SR), Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Longitudinal Interval Follow up Evaluation (LIFE). Depression recurrence and re-emergence of depressive symptoms were presented in a previous paper.
People receiving sertraline maintenance had better psychosocial outcomes compared to placebo (table). Depression recurrence was 6% with sertraline and 23% with placebo maintenance (NNT 6, 95% CI 4 to 15; relative risk reduction 74%, 95% CI 49% to 99%). Symptom re-emergence was 26% with sertraline versus 50% with placebo (NNT 4, 95% CI 3 to 11, relative risk reduction 48%, 95% CI 25% to 71%).
18-month maintenance with sertraline, following response during short term treatment, improved psychosocial and symptom outcomes over placebo in chronic depression.
In this follow on study, only 38% of participants in the original (short-term) trial were eligible for randomisation into the maintenance phase and only 13% of the original sample completed this phase. Yet, the Sertraline Chronic Depressive Study Group is one of few groups which have focussed on long-term (maintenance) outcomes in chronic depression,1 so these results are important and worth considering. In a previous report, the group used “reduction of depressive symptoms” as the major outcome.2 In the present paper, the focus is on normalisation of functioning based on clinician and participant ratings.
In general, the scales measuring normalisation of functioning followed the symptomatic depression scales closely. The authors call for more “objective” measures of functioning using in vivo behavioural and work measures rather than the “surrogate” scales they have included. They excluded the purely subjective dimensions of the SF-36, such as the energy and mental health subscales. These subscales cover “psychological well-being”as reflected in the WHO-Five well-being scale.3 Positive psychological well-being is a more sensitive measure for predicting recurrence of depression than symptomatically negative well-being scales.4–5 Neither the SF-36 social functioning or role-emotional subscale discriminated between full and partial recovery in people with depression.
There is a high correlation between the Hamilton Depression Scale and the social functioning scales selected by the authors. This suggests that sertraline is superior to placebo in maintenance treatment for chronic depression. This corresponds to previous findings about the prevention of relapse and depression recurrence.1 Given the benign adverse effect profile, the prophylactic properties of this class of antidepressants appear to be of great importance for managing chronic depression.
For correspondence: J Kocsis, Cornell University School of Medicine, New York.
Source of funding: Pfizer Inc.
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