Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment

Background: Treatment-resistant depression (TRD) is defined as the failure of at least two antidepressants in adequate doses and timing during a major depressive episode. Esketamine intranasal (ESK-IN) has been approved by the Food and Drug Administration and the European Medicines Agency for the tr...

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Autores: Gutiérrez-Rojas, L, Vendrell-Serres, J, Ramos-Quiroga, JA, Etxeandia-Pradera, JI, Aguilar, E, De Santiago-Díaz, AI, Hernández-Huerta, D, Tordera, V, Vázquez-Ventoso, C, Bolívar, M, Abril, A, Catalán-Barragán, R, García-Jiménez, J
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:dnet:r-fisabio___::54b20c939a2e9ebfa35b56133e6d741f
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/20704
Access Level:acceso abierto
Palabra clave:Intranasal esketamine
treatment-resistant depression
compassionate use
functional impairment
psychotherapy
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spelling Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatmentGutiérrez-Rojas, LVendrell-Serres, JRamos-Quiroga, JAEtxeandia-Pradera, JIAguilar, EDe Santiago-Díaz, AIHernández-Huerta, DTordera, VVázquez-Ventoso, CBolívar, MAbril, ACatalán-Barragán, RGarcía-Jiménez, JIntranasal esketaminetreatment-resistant depressioncompassionate usefunctional impairmentpsychotherapyBackground: Treatment-resistant depression (TRD) is defined as the failure of at least two antidepressants in adequate doses and timing during a major depressive episode. Esketamine intranasal (ESK-IN) has been approved by the Food and Drug Administration and the European Medicines Agency for the treatment of TRD in combination with other antidepressants.Aims: To assess the effectiveness and tolerability of a sample of TRD patients who received treatment with ESK-IN as part of the compassionate use program.Methods: A retrospective, observational study was carried out on patients with a diagnosis of TRD enrolled in the early access program of ESK-IN in nine centers. Effectiveness was assessed with the Montgomery-Asberg depression rating scale (MADRS) at four time points: baseline, 28, 90, and 180 days of treatment.Results: The sample included 71 patients (70% women) with a mean baseline MADRS score of 38.27 +/- 5.9 and total or partial work disability rates of 85%. ESK-IN treatment was associated with a statistically and clinically significant reduction in the severity of depressive symptoms at all time points assessed. The presence of side effects was common but the majority were mild in severity and resolved after the observation period. Those patients who received psychotherapy in combination with ESK-IN showed a significantly lower MADRS score at 90 and 180 days than those patients who did not undergo psychotherapy.Conclusion: ESK-IN has proven to be effective and safe in a clinical sample of patients with severe TRD. To optimize clinical outcomes, the pharmacological treatment for TRD should always be integrated into a comprehensive therapeutic plan that encompasses strategies such as psychotherapy, social support, and family interventions.SAGE PUBLICATIONS LTD2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/20704JOURNAL OF PSYCHOPHARMACOLOGYISSN: 02698811ISSNe: 14617285reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:dnet:r-fisabio___::54b20c939a2e9ebfa35b56133e6d741f2026-06-11T12:45:17Z
dc.title.none.fl_str_mv Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment
title Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment
spellingShingle Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment
Gutiérrez-Rojas, L
Intranasal esketamine
treatment-resistant depression
compassionate use
functional impairment
psychotherapy
title_short Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment
title_full Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment
title_fullStr Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment
title_full_unstemmed Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment
title_sort Compassionate use of esketamine intranasal in patients with severe major depressive disorder resistant to the treatment
dc.creator.none.fl_str_mv Gutiérrez-Rojas, L
Vendrell-Serres, J
Ramos-Quiroga, JA
Etxeandia-Pradera, JI
Aguilar, E
De Santiago-Díaz, AI
Hernández-Huerta, D
Tordera, V
Vázquez-Ventoso, C
Bolívar, M
Abril, A
Catalán-Barragán, R
García-Jiménez, J
author Gutiérrez-Rojas, L
author_facet Gutiérrez-Rojas, L
Vendrell-Serres, J
Ramos-Quiroga, JA
Etxeandia-Pradera, JI
Aguilar, E
De Santiago-Díaz, AI
Hernández-Huerta, D
Tordera, V
Vázquez-Ventoso, C
Bolívar, M
Abril, A
Catalán-Barragán, R
García-Jiménez, J
author_role author
author2 Vendrell-Serres, J
Ramos-Quiroga, JA
Etxeandia-Pradera, JI
Aguilar, E
De Santiago-Díaz, AI
Hernández-Huerta, D
Tordera, V
Vázquez-Ventoso, C
Bolívar, M
Abril, A
Catalán-Barragán, R
García-Jiménez, J
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Intranasal esketamine
treatment-resistant depression
compassionate use
functional impairment
psychotherapy
topic Intranasal esketamine
treatment-resistant depression
compassionate use
functional impairment
psychotherapy
description Background: Treatment-resistant depression (TRD) is defined as the failure of at least two antidepressants in adequate doses and timing during a major depressive episode. Esketamine intranasal (ESK-IN) has been approved by the Food and Drug Administration and the European Medicines Agency for the treatment of TRD in combination with other antidepressants.Aims: To assess the effectiveness and tolerability of a sample of TRD patients who received treatment with ESK-IN as part of the compassionate use program.Methods: A retrospective, observational study was carried out on patients with a diagnosis of TRD enrolled in the early access program of ESK-IN in nine centers. Effectiveness was assessed with the Montgomery-Asberg depression rating scale (MADRS) at four time points: baseline, 28, 90, and 180 days of treatment.Results: The sample included 71 patients (70% women) with a mean baseline MADRS score of 38.27 +/- 5.9 and total or partial work disability rates of 85%. ESK-IN treatment was associated with a statistically and clinically significant reduction in the severity of depressive symptoms at all time points assessed. The presence of side effects was common but the majority were mild in severity and resolved after the observation period. Those patients who received psychotherapy in combination with ESK-IN showed a significantly lower MADRS score at 90 and 180 days than those patients who did not undergo psychotherapy.Conclusion: ESK-IN has proven to be effective and safe in a clinical sample of patients with severe TRD. To optimize clinical outcomes, the pharmacological treatment for TRD should always be integrated into a comprehensive therapeutic plan that encompasses strategies such as psychotherapy, social support, and family interventions.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fisabio.portalinvestigacion.com/publicaciones/20704
url https://fisabio.portalinvestigacion.com/publicaciones/20704
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv SAGE PUBLICATIONS LTD
publisher.none.fl_str_mv SAGE PUBLICATIONS LTD
dc.source.none.fl_str_mv JOURNAL OF PSYCHOPHARMACOLOGY
ISSN: 02698811
ISSNe: 14617285
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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