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Background: Depression is quite common among cancer patients. It has yet to be determined which antidepressant is the most effective in cancer patients with depression. Methods: The present study included 21 consecutive depressed oncology patients of whom 19 were followed up for 6 months. All patients initially received mirtazapine 15 mg/day and the dose was increased in the absence of significant treatment response and adverse effects. Results: Depressive symptoms diminished at the end of month 1 and this improvement was maintained for the remaining 23 weeks of the study. Mean 17-item Hamilton Rating Scale for Depression (HAM-D-17) scores fell significantly from 21.4 ± 4.9 at baseline to 6.5 ± 3.2 at the end of the first month of treatment (p < 0.001). Among the 19 patients who were followed up, five reported at least one adverse effect during treatment; however, the vast majority of these adverse effects were described as mild to moderate. Conclusion: This prospective, open-label study provides preliminary evidence regarding the efficacy, safety and tolerability of mirtazapine treatment in cancer patients with depression. Relatively low doses of mirtazapine appeared to be safe and effective for treating cancer patients undergoing radiotherapy and/or chemotherapy, and the reduction in the severity of depressive symptoms was maintained until the end of the 24-week treatment period. [ABSTRACT FROM AUTHOR]