Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)

Jamieson, C. (Carol)|||/items/06dd0ab4-2940-4579-ad89-e8c07901b938; Canuso, C.M. (Carla M.)|||/items/e0fe6005-e25e-4e1d-8baf-3112f7f3d157; Ionescu, D.F. (Dawn F.)|||/items/f48ad159-eb0f-4aa6-b489-3e6607b45f46; Lane, R. (Rosanne)|||/items/c7cb11d0-2fe1-4a4a-9ff7-1c84d947b78f; Qiu, X. (Xin)|||/items/68b8a7bb-8d59-49d0-b874-ab4cc79ced8a; Rozjabek, H. (Heather)|||/items/06f73c1e-e113-4e56-b3c0-b5a21eeb848a; Molero, P. (Patricio)|||/items/741e3eb0-ce54-4791-a178-c126bf0d4469; Fu, D.J. (Dong-Jing)|||/items/9cf4d52e-1b1e-42a6-9aee-08017e7ac43b

Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)

Purpose: To assess the effect of esketamine nasal spray on patient-reported outcomes (PROs) in patients with major depressive disorder having active suicidal ideation with intent (MDSI). Methods: Patient-level data from two phase 3 studies (ASPIRE I; ASPIRE II) of esketamine + standard of care (SOC)...

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Autores:	Jamieson, C. (Carol)\|\|\|/items/06dd0ab4-2940-4579-ad89-e8c07901b938, Canuso, C.M. (Carla M.)\|\|\|/items/e0fe6005-e25e-4e1d-8baf-3112f7f3d157, Ionescu, D.F. (Dawn F.)\|\|\|/items/f48ad159-eb0f-4aa6-b489-3e6607b45f46, Lane, R. (Rosanne)\|\|\|/items/c7cb11d0-2fe1-4a4a-9ff7-1c84d947b78f, Qiu, X. (Xin)\|\|\|/items/68b8a7bb-8d59-49d0-b874-ab4cc79ced8a, Rozjabek, H. (Heather)\|\|\|/items/06f73c1e-e113-4e56-b3c0-b5a21eeb848a, Molero, P. (Patricio)\|\|\|/items/741e3eb0-ce54-4791-a178-c126bf0d4469, Fu, D.J. (Dong-Jing)\|\|\|/items/9cf4d52e-1b1e-42a6-9aee-08017e7ac43b
Tipo de recurso:	artículo
Fecha de publicación:	2023
País:	España
Institución:	Universidad de Navarra
Repositorio:	Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:	inglés
OAI Identifier:	oai:dadun.unav.edu:10171/67552
Acceso en línea:	https://hdl.handle.net/10171/67552
Access Level:	acceso abierto
Palabra clave:	Esketamine Suicidal ideation Pooled analysis Patient-reported outcomes Major depressive disorder

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network_name_str	España
repository_id_str
spelling	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)Jamieson, C. (Carol)\|\|\|/items/06dd0ab4-2940-4579-ad89-e8c07901b938Canuso, C.M. (Carla M.)\|\|\|/items/e0fe6005-e25e-4e1d-8baf-3112f7f3d157Ionescu, D.F. (Dawn F.)\|\|\|/items/f48ad159-eb0f-4aa6-b489-3e6607b45f46Lane, R. (Rosanne)\|\|\|/items/c7cb11d0-2fe1-4a4a-9ff7-1c84d947b78fQiu, X. (Xin)\|\|\|/items/68b8a7bb-8d59-49d0-b874-ab4cc79ced8aRozjabek, H. (Heather)\|\|\|/items/06f73c1e-e113-4e56-b3c0-b5a21eeb848aMolero, P. (Patricio)\|\|\|/items/741e3eb0-ce54-4791-a178-c126bf0d4469Fu, D.J. (Dong-Jing)\|\|\|/items/9cf4d52e-1b1e-42a6-9aee-08017e7ac43bEsketamineSuicidal ideationPooled analysisPatient-reported outcomesMajor depressive disorderPurpose: To assess the effect of esketamine nasal spray on patient-reported outcomes (PROs) in patients with major depressive disorder having active suicidal ideation with intent (MDSI). Methods: Patient-level data from two phase 3 studies (ASPIRE I; ASPIRE II) of esketamine + standard of care (SOC) in patients (aged 18-64 years) with MDSI, were pooled. PROs were evaluated from baseline through end of the double-blind treatment phase (day 25). Outcome assessments included: Beck Hopelessness Scale (BHS), Quality of Life (QoL) in Depression Scale (QLDS), European QoL Group-5-Dimension-5-Level (EQ-5D-5L), and 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Changes in BHS and QLDS scores (baseline to day 25) were analyzed using a mixed-effects model for repeated measures (MMRM). Results: Pooled data for esketamine + SOC (n = 226; mean age: 40.5 years, 59.3% females) and placebo + SOC (n = 225; mean age: 39.6 years, 62.2% females) were analyzed. Mean ± SD change from baseline to day 25, esketamine + SOC vs placebo + SOC (least-square mean difference [95% CI] based on MMRM): BHS total score, - 7.4 ± 6.7 vs - 6.8 ± 6.5 [- 1.0 (- 2.23, 0.21)]; QLDS score, - 14.4 ± 11.5 vs - 12.2 ± 10.8 [- 3.1 (- 5.21, - 1.02)]. Relative risk (95% CI) of reporting perceived problems (slight to extreme) in EQ-5D-5L dimensions (day 25) in esketamine + SOC vs placebo + SOC: mobility [0.78 (0.50, 1.20)], self-care [0.83 (0.55, 1.27)], usual activities [0.87 (0.72, 1.05)], pain/discomfort [0.85 (0.69, 1.04)], and anxiety/depression [0.90 (0.80, 1.00)]. Mean ± SD changes from baseline in esketamine + SOC vs placebo + SOC for health status index: 0.23 ± 0.21 vs 0.19 ± 0.22; and for EQ-Visual Analogue Scale: 24.0 ± 27.2 vs 19.3 ± 24.4. At day 25, mean ± SD in domains of TSQM-9 scores in esketamine + SOC vs placebo + SOC were: effectiveness, 67.2 ± 25.3 vs 56.2 ± 26.8; global satisfaction, 69.9 ± 25.2 vs 56.3 ± 27.8; and convenience, 74.0 ± 19.4 vs 75.4 ± 18.7. Conclusion: These PRO data support the patient perspective of the effect associated with esketamine + SOC in improving health-related QoL in patients with MDSI. Trial registration: ClinicalTrials.gov Identifier: ASPIRE I, NCT03039192 (Registration date: February 1, 2017); ASPIRE II, NCT03097133 (Registration date: March 31, 2017).Dadun. Depósito Académico Digital Universidad de Navarra20232023-10-0220232023-01-0120232023-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/67552reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/675522026-06-21T12:47:57Z
dc.title.none.fl_str_mv	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)
title	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)
spellingShingle	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II) Jamieson, C. (Carol)\|\|\|/items/06dd0ab4-2940-4579-ad89-e8c07901b938 Esketamine Suicidal ideation Pooled analysis Patient-reported outcomes Major depressive disorder
title_short	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)
title_full	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)
title_fullStr	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)
title_full_unstemmed	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)
title_sort	Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)
dc.creator.none.fl_str_mv	Jamieson, C. (Carol)\|\|\|/items/06dd0ab4-2940-4579-ad89-e8c07901b938 Canuso, C.M. (Carla M.)\|\|\|/items/e0fe6005-e25e-4e1d-8baf-3112f7f3d157 Ionescu, D.F. (Dawn F.)\|\|\|/items/f48ad159-eb0f-4aa6-b489-3e6607b45f46 Lane, R. (Rosanne)\|\|\|/items/c7cb11d0-2fe1-4a4a-9ff7-1c84d947b78f Qiu, X. (Xin)\|\|\|/items/68b8a7bb-8d59-49d0-b874-ab4cc79ced8a Rozjabek, H. (Heather)\|\|\|/items/06f73c1e-e113-4e56-b3c0-b5a21eeb848a Molero, P. (Patricio)\|\|\|/items/741e3eb0-ce54-4791-a178-c126bf0d4469 Fu, D.J. (Dong-Jing)\|\|\|/items/9cf4d52e-1b1e-42a6-9aee-08017e7ac43b
author	Jamieson, C. (Carol)\|\|\|/items/06dd0ab4-2940-4579-ad89-e8c07901b938
author_facet	Jamieson, C. (Carol)\|\|\|/items/06dd0ab4-2940-4579-ad89-e8c07901b938 Canuso, C.M. (Carla M.)\|\|\|/items/e0fe6005-e25e-4e1d-8baf-3112f7f3d157 Ionescu, D.F. (Dawn F.)\|\|\|/items/f48ad159-eb0f-4aa6-b489-3e6607b45f46 Lane, R. (Rosanne)\|\|\|/items/c7cb11d0-2fe1-4a4a-9ff7-1c84d947b78f Qiu, X. (Xin)\|\|\|/items/68b8a7bb-8d59-49d0-b874-ab4cc79ced8a Rozjabek, H. (Heather)\|\|\|/items/06f73c1e-e113-4e56-b3c0-b5a21eeb848a Molero, P. (Patricio)\|\|\|/items/741e3eb0-ce54-4791-a178-c126bf0d4469 Fu, D.J. (Dong-Jing)\|\|\|/items/9cf4d52e-1b1e-42a6-9aee-08017e7ac43b
author_role	author
author2	Canuso, C.M. (Carla M.)\|\|\|/items/e0fe6005-e25e-4e1d-8baf-3112f7f3d157 Ionescu, D.F. (Dawn F.)\|\|\|/items/f48ad159-eb0f-4aa6-b489-3e6607b45f46 Lane, R. (Rosanne)\|\|\|/items/c7cb11d0-2fe1-4a4a-9ff7-1c84d947b78f Qiu, X. (Xin)\|\|\|/items/68b8a7bb-8d59-49d0-b874-ab4cc79ced8a Rozjabek, H. (Heather)\|\|\|/items/06f73c1e-e113-4e56-b3c0-b5a21eeb848a Molero, P. (Patricio)\|\|\|/items/741e3eb0-ce54-4791-a178-c126bf0d4469 Fu, D.J. (Dong-Jing)\|\|\|/items/9cf4d52e-1b1e-42a6-9aee-08017e7ac43b
author2_role	author author author author author author author
dc.contributor.none.fl_str_mv	Dadun. Depósito Académico Digital Universidad de Navarra
dc.subject.none.fl_str_mv	Esketamine Suicidal ideation Pooled analysis Patient-reported outcomes Major depressive disorder
topic	Esketamine Suicidal ideation Pooled analysis Patient-reported outcomes Major depressive disorder
description	Purpose: To assess the effect of esketamine nasal spray on patient-reported outcomes (PROs) in patients with major depressive disorder having active suicidal ideation with intent (MDSI). Methods: Patient-level data from two phase 3 studies (ASPIRE I; ASPIRE II) of esketamine + standard of care (SOC) in patients (aged 18-64 years) with MDSI, were pooled. PROs were evaluated from baseline through end of the double-blind treatment phase (day 25). Outcome assessments included: Beck Hopelessness Scale (BHS), Quality of Life (QoL) in Depression Scale (QLDS), European QoL Group-5-Dimension-5-Level (EQ-5D-5L), and 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Changes in BHS and QLDS scores (baseline to day 25) were analyzed using a mixed-effects model for repeated measures (MMRM). Results: Pooled data for esketamine + SOC (n = 226; mean age: 40.5 years, 59.3% females) and placebo + SOC (n = 225; mean age: 39.6 years, 62.2% females) were analyzed. Mean ± SD change from baseline to day 25, esketamine + SOC vs placebo + SOC (least-square mean difference [95% CI] based on MMRM): BHS total score, - 7.4 ± 6.7 vs - 6.8 ± 6.5 [- 1.0 (- 2.23, 0.21)]; QLDS score, - 14.4 ± 11.5 vs - 12.2 ± 10.8 [- 3.1 (- 5.21, - 1.02)]. Relative risk (95% CI) of reporting perceived problems (slight to extreme) in EQ-5D-5L dimensions (day 25) in esketamine + SOC vs placebo + SOC: mobility [0.78 (0.50, 1.20)], self-care [0.83 (0.55, 1.27)], usual activities [0.87 (0.72, 1.05)], pain/discomfort [0.85 (0.69, 1.04)], and anxiety/depression [0.90 (0.80, 1.00)]. Mean ± SD changes from baseline in esketamine + SOC vs placebo + SOC for health status index: 0.23 ± 0.21 vs 0.19 ± 0.22; and for EQ-Visual Analogue Scale: 24.0 ± 27.2 vs 19.3 ± 24.4. At day 25, mean ± SD in domains of TSQM-9 scores in esketamine + SOC vs placebo + SOC were: effectiveness, 67.2 ± 25.3 vs 56.2 ± 26.8; global satisfaction, 69.9 ± 25.2 vs 56.3 ± 27.8; and convenience, 74.0 ± 19.4 vs 75.4 ± 18.7. Conclusion: These PRO data support the patient perspective of the effect associated with esketamine + SOC in improving health-related QoL in patients with MDSI. Trial registration: ClinicalTrials.gov Identifier: ASPIRE I, NCT03039192 (Registration date: February 1, 2017); ASPIRE II, NCT03097133 (Registration date: March 31, 2017).
publishDate	2023
dc.date.none.fl_str_mv	2023 2023-10-02 2023 2023-01-01 2023 2023-01-01
dc.type.none.fl_str_mv	journal article http://purl.org/coar/resource_type/c_6501
dc.type.openaire.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	https://hdl.handle.net/10171/67552
url	https://hdl.handle.net/10171/67552
dc.language.none.fl_str_mv	Inglés eng
language_invalid_str_mv	Inglés
language	eng
dc.rights.none.fl_str_mv	open access http://purl.org/coar/access_right/c_abf2
dc.rights.openaire.fl_str_mv	info:eu-repo/semantics/openAccess
rights_invalid_str_mv	open access http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.source.none.fl_str_mv	reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra instname:Universidad de Navarra
instname_str	Universidad de Navarra
reponame_str	Dadun. Depósito Académico Digital de la Universidad de Navarra
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Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)

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