Abstract

The objective of the study was to investigate the statement made by the US Department of Health and Human Services' Clinical Practice Guidelines of Major Depression in Primary Care (1993) that clinical management (CM) leads to remission in 20%-30% of the cases. A consecutive sample of 326 patients with major depression in primary care were randomized to a 6-month, double-blind treatment study of CM + placebo (PL) or one of two active drug arms: sertraline (S) + CM or mianserin (M) + CM. Patients were classified as responders if they fulfilled all three of the following criteria: 1) at least 50% reduction of the total MADRS score; 2) current state within no mental i l lness--mild depression severity (CGI); and 3) rated as much or very much improved (CGI) by the physician. Of patients with a first episode of major depression, 58% (n = 15) were responders to PL + CM after 8 weeks and 77% (n = 13) after 6 months of treatment. The efficacy of the active drug combinations did not differ statistically from CM + PL. If dropouts were included in the analyses (intention to treat data), percent of responders to placebo + CM was 50%. In patients with recurrent depression, 50% (n = 38) were responders to PL + CM after 8 weeks of treatment and 72% (n = 36) after 6 months. In comparison, 72% (n = 54) responded to CM + S after 8 weeks (p = 0.009) and 86% (n = 51) after 6 months; p = 0.06). The remission rate of depression following CM + PL in first episodes of major depression in primary care is higher than previously estimated and comparable to the remission rate achieved by adding an active drug. The findings question recent guidelines for the treatment of depression and suggest that recurrent depressions are neurobiologically different from first episodes.

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