TY - JOUR
T1 - Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment‐resistant depression
AU - the REAL‐ESK Study Group
AU - Martinotti, Giovanni
AU - Dell'Osso, Bernardo
AU - Di Lorenzo, Giorgio
AU - Maina, Giuseppe
AU - Bertolino, Alessandro
AU - Clerici, Massimo
AU - Barlati, Stefano
AU - Rosso, Gianluca
AU - Di Nicola, Marco
AU - Marcatili, Matteo
AU - d'Andrea, Giacomo
AU - Cavallotto, Clara
AU - Chiappini, Stefania
AU - De Filippis, Sergio
AU - Nicolò, Giuseppe
AU - De Fazio, Pasquale
AU - Andriola, Ileana
AU - Zanardi, Raffaella
AU - Nucifora, Domenica
AU - Di Mauro, Stefania
AU - Bassetti, Roberta
AU - Pettorruso, Mauro
AU - McIntyre, Roger S.
AU - Sensi, Stefano L.
AU - di Giannantonio, Massimo
AU - Vita, Antonio
AU - Baldacci, Giulia
AU - Belletti, Sandro
AU - Bellomo, Antonello
AU - Benatti, Beatrice
AU - Carminati, Matteo
AU - Carullo, Rosalba
AU - de Berardis, Domenico
AU - de Filippis, Renato
AU - Chiaie, Roberto Delle
AU - di Carlo, Francesco
AU - Di Petta, Gilberto
AU - Galluzzo, Alessandro
AU - Giorgelli, Valentina
AU - Lombardozzi, Ginevra
AU - Martiadis, Vassilis
AU - Mattei, Chiara
AU - Mosca, Alessio
AU - Niolu, Cinzia
AU - Olivola, Miriam
AU - Percudani, Mauro
AU - Pepe, Maria
AU - Rossi, Eros
AU - Scardigli, Maria Ilaria
AU - Tatì, Filippo
N1 - © 2023 The Authors. Bipolar Disorders published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives. https://creativecommons.org/licenses/by-nc-nd/4.0/
PY - 2023/1/18
Y1 - 2023/1/18
N2 - 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.
AB - 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.
KW - ORIGINAL ARTICLE
KW - ORIGINAL ARTICLES
KW - bipolar depression
KW - esketamine
KW - glutamate
KW - mood disorders
KW - pharmacological treatment
KW - rapid‐acting antidepressant
KW - real‐world study
KW - TRD
KW - treatment‐resistant depression
KW - real-world study
KW - rapid-acting antidepressant
KW - treatment-resistant depression
UR - http://www.scopus.com/inward/record.url?scp=85146615414&partnerID=8YFLogxK
U2 - 10.1111/bdi.13296
DO - 10.1111/bdi.13296
M3 - Article
SN - 1398-5647
VL - 25
SP - 233
EP - 244
JO - Bipolar Disorders
JF - Bipolar Disorders
IS - 3
ER -