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Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment-resistant depression |
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| Authors: | Giovanni Martinotti,Bernardo Dell'Osso,Giorgio Di Lorenzo,Giuseppe Maina,Alessandro Bertolino,Massimo Clerici,Stefano Barlati,Gianluca Rosso,Marco Di Nicola,Matteo Marcatili,Giacomo d'Andrea,Clara Cavallotto,Stefania Chiappini,Sergio De Filippis,Giuseppe Nicolò,Pasquale De Fazio,Ileana Andriola,Raffaella Zanardi,Domenica Nucifora,Stefania Di Mauro,Roberta Bassetti,Mauro Pettorruso,Roger S. McIntyre,Stefano L. Sensi,Massimo di Giannantonio,Antonio Vita,the REAL-ESK Study Group |
| Affiliation: | 1. Department of Neurosciences, Imaging and Clinical Sciences, Università degli Studi G. D'Annunzio, Chieti, Italy Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK;2. Department of Biomedical and Clinical Sciences Luigi Sacco and Aldo Ravelli Center for Neurotechnology and Brain Therapeutic, University of Milan, Milano, Italy;3. Chair of Psychiatry, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy;4. Department of Neurosciences Rita Levi Montalcini, University of Torino, Turin, Italy;5. Università degli Studi di Bari Aldo Moro, Italy;6. Department of Mental Health and Addiction, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy;7. Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy;8. Section of Psychiatry, Department of Neuroscience, Università Cattolica del Sacro Cuore, Rome, Italy Department of Psychiatry, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy;9. Department of Neurosciences, Imaging and Clinical Sciences, Università degli Studi G. D'Annunzio, Chieti, Italy;10. Neuropsychiatric Clinic, Villa Von Siebenthal, Genzano di Roma, Italy;11. Department of Mental Health and Addiction, ASL Roma 5, Rome, Italy;12. Psychiatry Unit, Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy;13. Mood Disorder Unit, Department of Clinical Neurosciences, IRCCS San Raffaele Scientific Institute, Milan, Italy Department of Clinical Neurosciences, University Vita-Salute San Raffaele, Milan, Italy;14. MDSMA Taormina-Messina Sud ASP di Messina, Messina, Italy;15. SPDC Frosinone - ASL Frosinone, Frosinone, Italy;16. Department of Mental Health and Addiction Services, Niguarda Hospital, Milan, Italy;17. Mood Disorders Psychopharmacology Unit, Poul Hansen Family Centre for Depression, University Health Network, ON, Toronto, Canada;18. Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy Department of Mental Health and Addiction Services, ASST Spedali Civili of Brescia, Italy |
| Abstract: | BackgroundBipolar depression accounts for most of the disease duration in type I and type II bipolar disorder (BD), with few treatment options, often poorly tolerated. Many individuals do not respond to first-line therapeutic options, resulting in treatment-resistant bipolar depression (B-TRD). Esketamine, the S-enantiomer of ketamine, has recently been approved for treatment-resistant depression (TRD), but no data are available on its use in B-TRD.ObjectivesTo compare the efficacy of esketamine in two samples of unipolar and bipolar TRD, providing preliminary indications of its effectiveness in B-TRD. Secondary outcomes included the evaluation of the safety and tolerability of esketamine in B-TRD, focusing on the average risk of an affective switch.MethodsThirty-five B-TRD subjects treated with esketamine nasal spray were enrolled and compared with 35 TRD patients. Anamnestic data and psychometric assessments (Montgomery-Asberg Depression Rating Scale/MADRS, Hamilton-depression scale/HAM-D, Hamilton-anxiety scale/HAM-A) were collected at baseline (T0), at one month (T1), and three months (T2) follow up.ResultsA significant reduction in depressive symptoms was found at T1 and T2 compared to T0, with no significant differences in response or remission rates between subjects with B-TRD and TRD. Esketamine showed a greater anxiolytic action in subjects with B-TRD than in those with TRD. Improvement in depressive symptoms was not associated with treatment-emergent affective switch.ConclusionsOur results supported the effectiveness and tolerability of esketamine in a real-world population of subjects with B-TRD. The low risk of manic switch in B-TRD patients confirmed the safety of this treatment. |
| Keywords: | bipolar depression esketamine glutamate mood disorders pharmacological treatment rapid-acting antidepressant real-world study TRD treatment-resistant depression |