A pilot study to evaluate symptom-oriented selection of antidepressants in patients with cancer

Major depressive disorder (MDD) is a common and debilitating illness in patients with cancer. However, the optimal treatment of depression in these patients remains uncertain, with limited evidence to support the use of pharmacologic therapy. We conducted a pilot study to evaluate the feasibility of an antidepressant clinical trial in the oncology population and the process of symptom-oriented selection of antidepressants (citalopram or mirtazapine) in patients with cancer and MDD.

This was a single center, two-arm, nonrandomized, open-label, nine-week pilot study of mirtazapine or citalopram in cancer patients with MDD. The primary endpoint was the feasibility to recruit and to retain patients. Secondary outcomes included changes in Patient Health Questionnaire-9 (PHQ-9) (depression), Functional Assessment of Cancer Therapy-General (FACT-G) (quality of life), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) (fatigue), and Pittsburgh Sleep Quality Index (PSQI) (sleep). We conducted descriptive statistics and responder analyses.

Of 21 patients, 18 (86%) successfully completed the study. An average of 2.8 subjects were enrolled per month. Mean scores on the PHQ-9 improved overall by 6.4 points (95% confidence interval [CI] 3.6-9.2). Additionally, mean FACT-G, FACIT-Fatigue, and PSQI scores improved in both study arms.

Conducting antidepressant clinical trials is challenging in the oncology population. We approached but did not meet our feasibility goals. Depression and quality of life (QOL) scores improved with both mirtazapine and citalopram, but evidence-based pharmacologic treatments for depression in cancer patients are needed.