A phase II study of methylphenidate for depression in advanced cancer

This study evaluated the use of methylphenidate for depression in advanced cancer. Design: Phase II open-label prospective study. Eligibility criteria: No previous use of methylphenidate or current use of other antidepressants. Evaluation: Depression and response to treatment were determined by asking the patient: “are you depressed?” Patients were assessed at baseline and at days 3, 5, and 7. Treatment: Starting dose was 5 mg at 8:00 a.m. and 12:00 noon. The dose was titrated for lack of response on any of the assessment days. Response criteria: A negative response to the question: “are you depressed?” Results: Some 41 patients were enrolled and 30 (15 men, 15 women) completed the study. Median age was 68 years (range: 30-90). Methylphenidate was stopped for six patients because of side effects and five were not evaluable; 21 responded to 10 mg/day on day 3; the other nine responded to 20 mg/day on day 5; 29 maintained their positive response through day 7. Anorexia, fatigue, concentration, and sedation also improved in some. All who completed the study had tolerable side effects, none of which caused treatment to stop. Conclusions: Methylphenidate is effective for depression in advanced cancer. A starting dose of 10 mg in divided doses is effective in most patients. Dose escalation may be needed. Improvement occurs within three days. Close monitoring of side effects is recommended.