The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment

Background Selective serotonin reuptake inhibitors (SSRIs) are the first-line treatment for major depressive disorder (MDD), but initial outcomes can be modest. Aims To compare SSRI dose optimisation with four alternative second-line strategies in MDD patients unresponsive to an SSRI. Method Of 257...

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Autores: Pérez, V, Puigdemont, D, de Diego-Adeliño, J, Elices, M, Leal, I, Cabello, M, Rodriguez-Jimenez, R, Alvarez-Mon, MA, García-Fernández, L, García-Iturrospe, EJA, Escartí, MJ, Montejo, AL, Montes, JM, Usall, J, Gallego-Nogueras, A, Lujan, E, López-Carrilero, R, González-Pinto, A, Ortiz-Jauregui, A, Blanch, J, Urretavizcaya, M, Colom, F, García-Campayo, J, Ayuso-Mateos, JL
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:fisabio.fundanetsuite.com:p19110
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/19110
Access Level:acceso abierto
Palabra clave:Major depressive disorder
treatment resistant depression
selective serotonin reuptake inhibitors
antidepressants
psychotherapy
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spelling The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatmentPérez, VPuigdemont, Dde Diego-Adeliño, JElices, MLeal, ICabello, MRodriguez-Jimenez, RAlvarez-Mon, MAGarcía-Fernández, LGarcía-Iturrospe, EJAEscartí, MJMontejo, ALMontes, JMUsall, JGallego-Nogueras, ALujan, ELópez-Carrilero, RGonzález-Pinto, AOrtiz-Jauregui, ABlanch, JUrretavizcaya, MColom, FGarcía-Campayo, JAyuso-Mateos, JLMajor depressive disordertreatment resistant depressionselective serotonin reuptake inhibitorsantidepressantspsychotherapyBackground Selective serotonin reuptake inhibitors (SSRIs) are the first-line treatment for major depressive disorder (MDD), but initial outcomes can be modest. Aims To compare SSRI dose optimisation with four alternative second-line strategies in MDD patients unresponsive to an SSRI. Method Of 257 participants, 51 were randomised to SSRI dose optimisation (SSRI-Opt), 46 to lithium augmentation (SSRI+Li), 48 to nortriptyline combination (SSRI+NTP), 55 to switch to venlafaxine (VEN) and 57 to problem-solving therapy (SSRI+PST). Primary outcomes were week-6 response/remission rates, assessed by blinded evaluators using the 17-item Hamilton Depression Rating Scale (HDRS-17). Changes in HDRS-17 scores, global improvement and safety outcomes were also explored. EudraCT No. 2007-002130-11. Results Alternative second-line strategies led to higher response (28.2% v. 14.3%, odds ratio = 2.36 [95% CI 1.0-5.6], p = 0.05) and remission (16.9% v. 12.2%, odds ratio = 1.46, [95% CI 0.57-3.71], p = 0.27) rates, with greater HDRS-17 score reductions (-2.6 [95% CI -4.9 to -0.4], p = 0.021]) than SSRI-Opt. Significant/marginally significant effects were only observed in both response rates and HDRS-17 decreases for VEN (odds ratio = 2.53 [95% CI 0.94-6.80], p = 0.067; HDRS-17 difference: -2.7 [95% CI -5.5 to 0.0], p = 0.054) and for SSRI+PST (odds ratio = 2.46 [95% CI 0.92 to 6.62], p = 0.074; HDRS-17 difference: -3.1 [95% CI -5.8 to -0.3], p = 0.032). The SSRI+PST group reported the fewest adverse effects, while SSRI+NTP experienced the most (28.1% v. 75%; p < 0.01), largely mild. Conclusions Patients with MDD and insufficient response to SSRIs would benefit from any other second-line strategy aside from dose optimisation. With limited statistical power, switching to venlafaxine and adding psychotherapy yielded the most consistent results in the DEPRE'5 study.CAMBRIDGE UNIV PRESS2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/19110BRITISH JOURNAL OF PSYCHIATRYISSN: 00071250ISSNe: 14721465reponame: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:fisabio.fundanetsuite.com:p191102026-06-11T12:45:17Z
dc.title.none.fl_str_mv The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment
title The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment
spellingShingle The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment
Pérez, V
Major depressive disorder
treatment resistant depression
selective serotonin reuptake inhibitors
antidepressants
psychotherapy
title_short The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment
title_full The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment
title_fullStr The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment
title_full_unstemmed The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment
title_sort The DEPRE'5 study: pragmatic, multicentre, five-arm, parallel-group randomised controlled trial with blinded assessment to compare treatment strategies in major depression after a failed selective serotonin reuptake inhibitor treatment
dc.creator.none.fl_str_mv Pérez, V
Puigdemont, D
de Diego-Adeliño, J
Elices, M
Leal, I
Cabello, M
Rodriguez-Jimenez, R
Alvarez-Mon, MA
García-Fernández, L
García-Iturrospe, EJA
Escartí, MJ
Montejo, AL
Montes, JM
Usall, J
Gallego-Nogueras, A
Lujan, E
López-Carrilero, R
González-Pinto, A
Ortiz-Jauregui, A
Blanch, J
Urretavizcaya, M
Colom, F
García-Campayo, J
Ayuso-Mateos, JL
author Pérez, V
author_facet Pérez, V
Puigdemont, D
de Diego-Adeliño, J
Elices, M
Leal, I
Cabello, M
Rodriguez-Jimenez, R
Alvarez-Mon, MA
García-Fernández, L
García-Iturrospe, EJA
Escartí, MJ
Montejo, AL
Montes, JM
Usall, J
Gallego-Nogueras, A
Lujan, E
López-Carrilero, R
González-Pinto, A
Ortiz-Jauregui, A
Blanch, J
Urretavizcaya, M
Colom, F
García-Campayo, J
Ayuso-Mateos, JL
author_role author
author2 Puigdemont, D
de Diego-Adeliño, J
Elices, M
Leal, I
Cabello, M
Rodriguez-Jimenez, R
Alvarez-Mon, MA
García-Fernández, L
García-Iturrospe, EJA
Escartí, MJ
Montejo, AL
Montes, JM
Usall, J
Gallego-Nogueras, A
Lujan, E
López-Carrilero, R
González-Pinto, A
Ortiz-Jauregui, A
Blanch, J
Urretavizcaya, M
Colom, F
García-Campayo, J
Ayuso-Mateos, JL
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Major depressive disorder
treatment resistant depression
selective serotonin reuptake inhibitors
antidepressants
psychotherapy
topic Major depressive disorder
treatment resistant depression
selective serotonin reuptake inhibitors
antidepressants
psychotherapy
description Background Selective serotonin reuptake inhibitors (SSRIs) are the first-line treatment for major depressive disorder (MDD), but initial outcomes can be modest. Aims To compare SSRI dose optimisation with four alternative second-line strategies in MDD patients unresponsive to an SSRI. Method Of 257 participants, 51 were randomised to SSRI dose optimisation (SSRI-Opt), 46 to lithium augmentation (SSRI+Li), 48 to nortriptyline combination (SSRI+NTP), 55 to switch to venlafaxine (VEN) and 57 to problem-solving therapy (SSRI+PST). Primary outcomes were week-6 response/remission rates, assessed by blinded evaluators using the 17-item Hamilton Depression Rating Scale (HDRS-17). Changes in HDRS-17 scores, global improvement and safety outcomes were also explored. EudraCT No. 2007-002130-11. Results Alternative second-line strategies led to higher response (28.2% v. 14.3%, odds ratio = 2.36 [95% CI 1.0-5.6], p = 0.05) and remission (16.9% v. 12.2%, odds ratio = 1.46, [95% CI 0.57-3.71], p = 0.27) rates, with greater HDRS-17 score reductions (-2.6 [95% CI -4.9 to -0.4], p = 0.021]) than SSRI-Opt. Significant/marginally significant effects were only observed in both response rates and HDRS-17 decreases for VEN (odds ratio = 2.53 [95% CI 0.94-6.80], p = 0.067; HDRS-17 difference: -2.7 [95% CI -5.5 to 0.0], p = 0.054) and for SSRI+PST (odds ratio = 2.46 [95% CI 0.92 to 6.62], p = 0.074; HDRS-17 difference: -3.1 [95% CI -5.8 to -0.3], p = 0.032). The SSRI+PST group reported the fewest adverse effects, while SSRI+NTP experienced the most (28.1% v. 75%; p < 0.01), largely mild. Conclusions Patients with MDD and insufficient response to SSRIs would benefit from any other second-line strategy aside from dose optimisation. With limited statistical power, switching to venlafaxine and adding psychotherapy yielded the most consistent results in the DEPRE'5 study.
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/19110
url https://fisabio.portalinvestigacion.com/publicaciones/19110
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 CAMBRIDGE UNIV PRESS
publisher.none.fl_str_mv CAMBRIDGE UNIV PRESS
dc.source.none.fl_str_mv BRITISH JOURNAL OF PSYCHIATRY
ISSN: 00071250
ISSNe: 14721465
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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