Objective: To determine whether prophylactic treatment with the antidepressant citalopram hydrobromide, compared with placebo, could prevent major depressive disorder in patients undergoing therapy for head and neck cancer (HNC).
Design: Prospective, randomized, placebo-controlled trial.
Setting: Academic medical center.
Patients: Thirty-six subjects were randomized, and 23 completed the study.
Interventions: Subjects were randomized to receive 40 mg of citalopram hydrobromide or matching placebo (herein after, citalopram group and placebo group, respectively) for 12 weeks with a final visit at 16 weeks.
Main outcome measures: The Hamilton Depression Rating Scale, psychiatric interview, and the University of Washington Quality of Life (UW-QOL) and Clinician Global Impression-Severity (CGI-S) scales.
Results: The numbers of subjects who met predefined cutoff criteria for depression during the 12 weeks of active study were 5 of 10 (50%) taking placebo and 2 of 12 (17%) taking citalopram (Fisher exact test, P = .17). No patients in the citalopram group became suicidal, compared with 2 in the placebo group. Global mood state at the conclusion of the study as measured by the CGI-S scale was rated as at least mildly ill in 15% of those receiving citalopram compared with 60% in the placebo group (Fisher exact test, P = .04). Quality of life, measured by the UW-QOL, deteriorated in both groups from baseline but less so in the citalopram group.
Conclusions: This study reports data from the first depression prevention trial in HNC and suggests that prophylactic treatment may decrease the incidence of depression during HNC therapy. The clinical significance of the reduction in depression was best demonstrated by the CGI-S scale, which showed a notable difference in global psychiatric and physical well-being.