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Efficacy of adjunctive infliximab vs placebo in the treatment of adults with bipolar I/II depression: A randomized clinical trial

JAMA May 15, 2019

McIntyre RS, et al. - In patients with bipolar I and II depression and inflammatory conditions, researchers evaluated the antidepressant effectiveness of adjunctive infliximab (a monoclonal antibody targeting tumor necrosis factor). They conducted a randomized, double-blind, placebo-controlled, parallel-group trial with 60 participants at two outpatient sites in Canada and the US, which lasted for 12 weeks. Participants were aged 18-65 years and met DSM-5-defined criteria for bipolar I or II depression with pretreatment biochemical and/or phenotypic evidence of inflammatory activation. A total of 60 patients were studied after administration of infliximab to 20 to 28 females, and placebo given to 26 to 30 females. Compared with placebo, infliximab is not significantly more efficacious for improving depressive symptoms in adults with a mood disorder. Further assessments reflected a noticeable decrease in depressive symptoms with infliximab treatment in comparison to placebo in a subpopulation of those reporting physical and/or sexual abuse.

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