PURPOSE: We sought to compare the effectiveness of physical exercise with that of treatment with antidepressant drugs routinely used in clinical practice, in terms of decreasing depressive symptomatology in patients aged >= 65 years who present with clinical criteria of a depressive episode. METHODS: We conducted a randomized clinical trial in a primary care setting. A total of 347 patients aged >= 65 years with a clinically significant depressive episode were randomized to participation in a supervised physical exercise program or to receive antidepressant treatment by their general practitioners. RESULTS: Intention-to-treat analysis showed that the cumulative incidence of improvement in depressive symptomatology (Montgomery-Asberg Depression Rating Scale score < 10) in the physical activity (PA) group after 1 month was not significantly different from that in the antidepressant treatment (AT) group. However, the proportion of those who showed improvement was significantly greater (p < 0.01) in the AT group (60.6% and 49.7%) compared to the PA group (45.6% and 32.9%) at the end of 3 and 6 months, respectively. The number of withdrawals was greater in the PA group (39.2% and 58.2%) compared to the AT group (22.6% and 40.0%) at 3 and 6 months, respectively, yet the proportion of participants with adverse side effects was greater in the AT group (8.9% versus 22.5%; p = 0.007). CONCLUSION: Although improvement was initially similar in both treatment groups, AT was superior in the medium term, despite giving rise to a greater number of adverse effects.

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