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. 2025 Jul 14.
doi: 10.1055/a-2579-9406. Online ahead of print.

Is Lumateperone Effective in Bipolar Depression? A Systematic Literature Review and Meta-Analysis on Placebo-Controlled Trials

Maurizio Pompili  1 , Mariarosaria Cifrodelli  2 , Maria Anna Trocchia  2 , Ludovica Longhini  2 , Anna Comparelli  1 , Roger S McIntyre  3   4 , Isabella Berardelli  1
Affiliations

Is Lumateperone Effective in Bipolar Depression? A Systematic Literature Review and Meta-Analysis on Placebo-Controlled Trials

Maurizio Pompili et al. Pharmacopsychiatry. .

Abstract

Bipolar depression is often difficult to treat and needs a specific therapeutic approach. This systematic review and meta-analysis aimed to evaluate the efficacy of lumateperone to be inclusive of more recently published studies with this agent in depressive episodes of bipolar disorder. Three meta-analyses were conducted to determine whether the mean Montgomery-Asberg Depression Rating Scale (MADRS) values in the placebo groups differ significantly from the mean MADRS scale values in the group receiving lumateperone 42 mg and whether the mean of Clinical Global Impression Bipolar Version - Severity Scale (CGI-BP-S) - (depression subscore and overall bipolar illness) values in the placebo groups differ significantly from the mean CGI-BP-S scale values in the group receiving lumateperone 42 mg. The meta-analysis showed a statistically significant difference between patients treated with lumateperone 42 mg and those treated with placebo for the MADRS and CGI subscores. The clinical profile of lumateperone indicates that it is a established and highly efficacious treatment option for major depressive episodes associated with bipolar disorder.

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Conflict of interest statement

Prof. M Pompili wishes to disclose that in the last five years, he has received lectures and advisory board honoraria or has engaged in clinical trial activities with Angelini Pharma, Allergan, Janssen, Lundbeck, Merck Sharp and Dohme, Otsuka, Rovi, Pfizer Inc, Fidia, Viatris, Recordati, Boehringer Ingelheim, Newron, GSK, and Teva, all of which are unrelated to this article. Dr. Roger S. McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Neurawell, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, Abbvie and Atai Life Sciences. Dr. S. Roger McIntyre is a CEO of Braxia Scientific Corp. I Berardelli disclosed that in the last five years, she has received consultant fees and/or lectures or has engaged in clinical trial activities with Angelini Pharma, Janssen Pharmaceuticals, Lundbeck, Rovi, all unrelated to this article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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