Efficacy of adjunctive infliximab vs placebo in the treatment of adults with bipolar I/II depression: A randomized clinical trial
JAMA Aug 14, 2019
McIntyre RS, Subramaniapillai M, Lee Y, et al. - In adults with bipolar I and bipolar II depression and inflammatory conditions, researchers evaluated the antidepressant effectiveness of adjunctive infliximab, a monoclonal antibody targeting tumor necrosis factor. In this 12-week, randomized, double-blind, placebo-controlled, parallel-group trial of 60 individuals carried out at two outpatient tertiary care sites in Canada and the United States, individuals were randomized to infliximab or to placebo across study sites. Overall baseline-to–endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score was noted across treatment × time interaction however, reduction in symptom severity was not notable at week 12. In which infliximab-treated individuals with a childhood history of physical abuse, larger reductions in MADRS total score and greater response rates were seen as part of a secondary analysis, where a significant treatment × time × childhood maltreatment interaction was noted. In adults with bipolar depression, infliximab vs placebo did not significantly decrease depressive symptoms. Moreover, outcomes from secondary analyses recognized a subpopulation (ie, those reporting physical and/or sexual abuse) that showed an significant decrease in depressive symptoms with infliximab treatment vs placebo
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