{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T07:14:51Z","timestamp":1768288491121,"version":"3.49.0"},"reference-count":36,"publisher":"Georg Thieme Verlag KG","issue":"01","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacopsychiatry"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Bipolar depression is often difficult to treat and needs a specific therapeutic\n                    approach. This systematic review and meta-analysis aimed to evaluate the\n                    efficacy of lumateperone to be inclusive of more recently published studies with\n                    this agent in depressive episodes of bipolar disorder. Three meta-analyses were\n                    conducted to determine whether the mean Montgomery-Asberg Depression Rating\n                    Scale (MADRS) values in the placebo groups differ significantly from the mean\n                    MADRS scale values in the group receiving lumateperone 42\u2009mg and whether the\n                    mean of Clinical Global Impression Bipolar Version - Severity Scale (CGI-BP-S) \u2013\n                    (depression subscore and overall bipolar illness) values in the placebo groups\n                    differ significantly from the mean CGI-BP-S scale values in the group receiving\n                    lumateperone 42\u2009mg. The meta-analysis showed a statistically significant\n                    difference between patients treated with lumateperone 42\u2009mg and those treated\n                    with placebo for the MADRS and CGI subscores. The clinical profile of\n                    lumateperone indicates that it is a established and highly efficacious treatment\n                    option for major depressive episodes associated with bipolar disorder.<\/jats:p>","DOI":"10.1055\/a-2579-9406","type":"journal-article","created":{"date-parts":[[2025,7,14]],"date-time":"2025-07-14T23:30:31Z","timestamp":1752535831000},"page":"5-14","source":"Crossref","is-referenced-by-count":0,"title":["Is Lumateperone Effective in Bipolar Depression? A Systematic\n                    Literature Review and Meta-Analysis on Placebo-Controlled Trials"],"prefix":"10.1055","volume":"59","author":[{"given":"Maurizio","family":"Pompili","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Mental Health and Sensory Organs, Faculty\n                    of Medicine and Psychology, Suicide Prevention Centre, Sant\u2019Andrea Hospital,\n                    Sapienza University of Rome, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariarosaria","family":"Cifrodelli","sequence":"additional","affiliation":[{"name":"Psychiatry Residency Training Program, Faculty of Medicine and\n                    Psychology, Sapienza University of Rome, Psychiatry Unit, Sant\u2019Andrea Hospital,\n                    Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Anna","family":"Trocchia","sequence":"additional","affiliation":[{"name":"Psychiatry Residency Training Program, Faculty of Medicine and\n                    Psychology, Sapienza University of Rome, Psychiatry Unit, Sant\u2019Andrea Hospital,\n                    Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ludovica","family":"Longhini","sequence":"additional","affiliation":[{"name":"Psychiatry Residency Training Program, Faculty of Medicine and\n                    Psychology, Sapienza University of Rome, Psychiatry Unit, Sant\u2019Andrea Hospital,\n                    Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Comparelli","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Mental Health and Sensory Organs, Faculty\n                    of Medicine and Psychology, Suicide Prevention Centre, Sant\u2019Andrea Hospital,\n                    Sapienza University of Rome, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roger S.","family":"McIntyre","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, University of Toronto, Toronto, ON,\n                    Canada"},{"name":"Department of Pharmacology, University of Toronto, ON,\n                    Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabella","family":"Berardelli","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Mental Health and Sensory Organs, Faculty\n                    of Medicine and Psychology, Suicide Prevention Centre, Sant\u2019Andrea Hospital,\n                    Sapienza University of Rome, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2025,7,14]]},"reference":[{"key":"ref1","volume-title":"Manic Depressive Illness. 2nd ed.","author":"F K Goodwin","year":"2007"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"1663","DOI":"10.1016\/S0140-6736(13)60989-7","article-title":"Bipolar 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patients","volume":"340","author":"M Pompili","year":"2023","journal-title":"J Affect Disord"},{"key":"ref19","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1055\/a-1348-1523","article-title":"Bipolar disorder and outcomes of monotherapy with lithium, valproate,\n                    quetiapine, olanzapine, venlafaxine, and citalopram","volume":"54","author":"J Bohlken","year":"2021","journal-title":"Pharmacopsychiatry"},{"key":"ref20","doi-asserted-by":"crossref","first-page":"1993","DOI":"10.1080\/03007995.2019.1636017","article-title":"Bipolar depression: The clinical characteristics and unmet needs of a complex\n                    disorder","volume":"35","author":"R S McIntyre","year":"2019","journal-title":"Curr Med Res Opin"},{"key":"ref21","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1016\/bs.apha.2020.09.001","article-title":"A review of the pharmacology and clinical profile of lumateperone for the\n                    treatment of schizophrenia","volume":"90","author":"G L Snyder","year":"2021","journal-title":"Adv Pharmacol"},{"key":"ref23","doi-asserted-by":"crossref","first-page":"971","DOI":"10.1016\/j.euroneuro.2019.06.008","article-title":"Novel antipsychotics specificity profile: A clinically oriented review of\n                    lurasidone, brexpiprazole, cariprazine and lumateperone","volume":"29","author":"F Corponi","year":"2019","journal-title":"Eur Neuropsychopharmacol"},{"key":"ref24","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.3390\/brainsci13081193","article-title":"Novel compounds in the treatment of schizophrenia-a selective review","volume":"13","author":"E M Tsapakis","year":"2023","journal-title":"Brain Sci"},{"key":"ref25","volume-title":"Lumateperone. 2023 Jul 17. In: StatPearls [Internet]","author":"D Cooper","year":"2025"},{"key":"ref26","doi-asserted-by":"crossref","first-page":"24932","DOI":"10.52965\/001c.24932","article-title":"Lumateperone tosylate, a selective and concurrent modulator of serotonin,\n                    dopamine, and glutamate, in the treatment of schizophrenia","volume":"9","author":"K Maini","year":"2021","journal-title":"Health Psychol Res"},{"key":"ref27","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1055\/a-2331-2300","article-title":"Discontinuation rate of lurasidone and quetiapine extended release in bipolar\n                    depression","volume":"57","author":"T Kishi","year":"2024","journal-title":"Pharmacopsychiatry"},{"key":"ref28","doi-asserted-by":"crossref","first-page":"244","DOI":"10.1097\/YIC.0000000000000371","article-title":"Safety and tolerability of lumateperone for the treatment of schizophrenia: A\n                    pooled analysis of late-phase placebo- and active-controlled 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Montgomery","year":"1979","journal-title":"Br J Psychiatry"},{"key":"ref32","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1016\/S0165-1781(97)00123-6","article-title":"Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar\n                    illness (BP): The CGI-BP","volume":"73","author":"M K Spearing","year":"1997","journal-title":"Psychiatry Res"},{"key":"ref33","doi-asserted-by":"crossref","first-page":"1098","DOI":"10.1176\/appi.ajp.2021.20091339","article-title":"Efficacy and safety of lumateperone for major depressive episodes associated\n                    with bipolar I or bipolar II disorder: A phase 3 randomized placebo-controlled\n                    trial","volume":"178","author":"J R Calabrese","year":"2021","journal-title":"Am J Psychiatry"},{"key":"ref34","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1016\/j.euroneuro.2022.12.012","article-title":"The efficacy of lumateperone on symptoms of depression in bipolar I and bipolar\n                    II disorder: Secondary and post hoc analyses","volume":"68","author":"R S McIntyre","year":"2023","journal-title":"Eur Neuropsychopharmacol"},{"key":"ref35","doi-asserted-by":"crossref","first-page":"22m14739","DOI":"10.4088\/JCP.22m14739","article-title":"The efficacy of lumateperone in patients with bipolar depression with mixed\n                    features","volume":"84","author":"R S McIntyre","year":"2023","journal-title":"J Clin Psychiatry"},{"key":"ref36","doi-asserted-by":"crossref","first-page":"478","DOI":"10.1111\/bdi.13310","article-title":"Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression:\n                    Results from a randomized placebo-controlled clinical trial","volume":"25","author":"T Suppes","year":"2023","journal-title":"Bipolar Disord"},{"key":"ref38","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1017\/S1092852923001591","article-title":"Long-term lumateperone treatment in bipolar disorder: Six-month open-label\n                    extension study","volume":"28","author":"M Tohen","year":"2023","journal-title":"CNS Spectrums"},{"key":"ref39","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1016\/S0165-1781(97)00123-6","article-title":"Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar\n                    illness (BP): The CGI-BP","volume":"73","author":"M K Spearing","year":"1997","journal-title":"Psychiatry Res"}],"container-title":["Pharmacopsychiatry"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2579-9406.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T23:33:06Z","timestamp":1768260786000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2579-9406"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,14]]},"references-count":36,"journal-issue":{"issue":"01","published-online":{"date-parts":[[2026,1,12]]},"published-print":{"date-parts":[[2026,1]]}},"URL":"https:\/\/doi.org\/10.1055\/a-2579-9406","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0176-3679","1439-0795"],"issn-type":[{"value":"0176-3679","type":"print"},{"value":"1439-0795","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,14]]}}}