Depression is a major complication of
cancer. The efficacy and safety of
mianserin were evaluated in a randomized placebo-controlled trial of 73 depressed women with
cancer. According to RDC diagnosis, all patients showed situational major depression. Both groups were well matched for
cancer localization, clinical stages, Karnofsky scores, duration of depression, baseline values on the Hamilton Depression Rating Scale (HDRS), Zung Self-Rating Depression Scale (ZSRDS), and Clinical Global Impression of Illness Severity (CGI-S), and for type of depression, whether dominantly depressive or depressive-anxious. Between days 7-21, there were significantly fewer dropouts with
mianserin (7) than with placebo (15). When compared with placebo, there were significant improvements for
mianserin for HDRS on days 7, 21 and 28, for ZSRDS on days 7 and 28, and for CGI-S on days 7, 14, 21 and 28. According to Clinical Global Impression of Illness Improvement (CGI-I) there were significantly more responders with
mianserin (28) than with placebo (18). The efficacy index for
mianserin was significantly greater than for placebo on days 21 and 28. At the end of the trial the scores for HDRS sleep disturbance factor and HDRS anxiety-somatization factor were significantly reduced for
mianserin than for placebo. There were no significant differences in side-effects between treatment groups. It is concluded that
mianserin is superior to placebo in reducing the severity and duration of depression which is present especially in patients with advanced
cancer.(ABSTRACT TRUNCATED AT 250 WORDS)