Background: Bipolar 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. Objectives: To 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. Methods: Thirty-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. Results: A 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. Conclusions: Our 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.

Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment-resistant depression / G. Martinotti, B. Dell'Osso, G. Dilorenzo, G. Maina, A. Bertolino, M. Clerici, S. Barlati, G. Rosso, M. Dinicola, M. Marcatili, G. D'Andrea, C. Cavallotto, S. Chiappini, S. Defilippis, G. Nicolo, P. Defazio, I. Andriola, R. Zanardi, D. Nucifora, S. Dimauro, R. Bassetti, M. Pettorruso, R.S. Mcintyre, S.L. Sensi, M. di Giannantonio, A. Vita, G. Baldacci, S. Belletti, A. Bellomo, B. Benatti, M. Carminati, R. Carullo, D. de Berardis, R. de Filippis, R.D. Chiaie, F. di Carlo, G. Di Petta, A. Galluzzo, V. Giorgelli, G. Lombardozzi, V. Martiadis, C. Mattei, A. Mosca, C. Niolu, M. Olivola, M. Percudani, M. Pepe, E. Rossi, M.I. Scardigli, F. Tati, A. Valchera, M. Vismara. - In: BIPOLAR DISORDERS. - ISSN 1398-5647. - (2023). [Epub ahead of print] [10.1111/bdi.13296]

Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment-resistant depression

B. Dell'Osso
Secondo
;
A. Bertolino;M. Marcatili;R. Bassetti;B. Benatti;A. Galluzzo;C. Mattei;A. Mosca;M. Vismara
Ultimo
2023

Abstract

Background: Bipolar 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. Objectives: To 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. Methods: Thirty-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. Results: A 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. Conclusions: Our 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.
TRD; bipolar depression; esketamine; glutamate; mood disorders; pharmacological treatment; rapid-acting antidepressant; real-world study; treatment-resistant depression
Settore MED/25 - Psichiatria
2023
13-gen-2023
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/953328
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