Development of an Integrated Program of Health Related Quality of Life Research for the National Surgical Adjuvant Breast and Bowel Project (NSABP)

Prescribing Tamoxifen in Patients With Mood Disorders

“…56 Finally, 3 of the cohort studies focusing on this issue indicated depression rates in patients assuming tamoxifen to be significantly higher, 47,54,76 whereas the others found no correlation between tamoxifen and depression risk. 75,78,79 It is important to acknowledge that all studies on tamoxifen antimanic action are hypothesis-driven clinical studies, 9 based on a robust etiopathogenetic premise, namely the link between PKC abnormal functioning and mania. 21,82 The majority of these research studies share a similar study design (double blind, randomized, 2 or 3 arms, placebo-controlled), similar trial samples (bipolar patients in acute manic or mixed phase, often on therapy with mood stabilizers) and, at the same time, similar limitations, such as short observation spans and small samples.…”

“…56,70,71,73 These findings may suggest a potential role of tamoxifen in exacerbating or triggering mood symptoms in subjects with an underlying predisposing diathesis or with a history of mood disorders. However, this issue deserves further investigation, since there are divergent results to be considered: for instance Day 78 in 2001 found no differences in depression prevalence between tamoxifen and placebo arms even in the group with high-risk for depression which had been previously identified through a stratification of the clinical sample. On the other hand, a recent case report describes the clinical improvement of a patient with BD during a long-term tamoxifen assumption due to breast cancer.…”

“…Four of these studies 47,54,76,77 reported a significantly higher risk of developing depression among patients who were assuming tamoxifen; this association was strengthened by the finding of rapid improvement after discontinuation. 76 Conversely, 5 studies 46,75,[78][79][80] did not find any relevant association between tamoxifen use and depression risk. As we will point out more precisely in the Discussion, the following points are remarkable.…”

“…Our review included 9 cohort studies 46,47,54,[75][76][77][78][79][80] conducted from 1991 75 to 2015 47 on patients who were assuming tamoxifen in breast cancer therapy or prophilaxis. Four of these studies 47,54,76,77 reported a significantly higher risk of developing depression among patients who were assuming tamoxifen; this association was strengthened by the finding of rapid improvement after discontinuation.…”