Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials

Stephane Borentain,1 David Williamson,2,3 Ibrahim Turkoz,4 Vanina Popova,5 William V McCall,3 Maju Mathews,1 Frank Wiegand1 1Department of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA; 2CNS Scientific Affairs Liaisons, Janssen Scientific Affairs, LLC, Titusvil...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Borentain S, Williamson D, Turkoz I, Popova V, McCall WV, Mathews M, Wiegand F
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	esketamine treatment-resistant depression sleep disturbance insomnia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/93725af22f134674b4a3df3ba7a0c03f
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:93725af22f134674b4a3df3ba7a0c03f
record_format	dspace
spelling	oai:doaj.org-article:93725af22f134674b4a3df3ba7a0c03f2021-11-30T18:50:37ZEffect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials1178-2021https://doaj.org/article/93725af22f134674b4a3df3ba7a0c03f2021-11-01T00:00:00Zhttps://www.dovepress.com/effect-of-sleep-disturbance-on-efficacy-of-esketamine-in-treatment-res-peer-reviewed-fulltext-article-NDThttps://doaj.org/toc/1178-2021Stephane Borentain,1 David Williamson,2,3 Ibrahim Turkoz,4 Vanina Popova,5 William V McCall,3 Maju Mathews,1 Frank Wiegand1 1Department of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA; 2CNS Scientific Affairs Liaisons, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA; 4Department of Clinical Statistics, Janssen Research & Development, LLC, Titusville, NJ, USA; 5Department of Neuroscience Clinical Development, Janssen Research & Development, Beerse, BelgiumCorrespondence: Stephane BorentainDepartment of Global Medical Affairs, Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USATel +1 609-7304420Email SBorent1@ITS.JNJ.comPurpose: To evaluate the relationship of sleep disturbance to the antidepressant effects of esketamine.Materials and Methods: Two double-blind, 4-week studies randomized adults with treatment-resistant depression (TRD) to placebo or esketamine nasal spray, each with newly initiated antidepressant. Sleep was assessed using Montgomery–Åsberg Depression Rating Scale (MADRS) item 4. Change in response (≥ 50% decrease in MADRS total score) and remission (total MADRS score ≤ 12) at day 28 was examined by presence/absence of baseline sleep disturbance using logistic regression models. Impact on reported sleep disturbance (MADRS item 4 score) was examined using ANCOVA models.Results: At baseline, most patients reported disturbed sleep – moderate/severe (65.3%, 369/565), mild (25.3%, 143/565), or none/slightly (9.4%, 53/565) – with similar distribution between treatment groups. A higher proportion of esketamine-treated patients achieved response (OR = 2.05; 95% CI: 1.40– 3.02; P < 0.001) and remission (OR = 1.81; 95% CI: 1.23– 2.66; P = 0.003) at day 28 compared to antidepressant plus placebo, regardless of presence/severity of sleep disturbance. Consistent with this, sleep (MADRS item 4 score) improved in both groups after the first dose, more so with esketamine by day 8 (between-group difference: P ≤ 0.02 at all time points). Across both treatment groups, 1-point improvement in sleep at day 8 increased the probability of antidepressant response on day 28 by 26% (OR = 1.26, 95% CI: 1.12– 1.42; P < 0.001), and remission by 28% (OR = 1.28, 95% CI: 1.14– 1.43; P < 0.001).Conclusion: Antidepressant efficacy of esketamine was demonstrated in patients with TRD, regardless of the presence of sleep disturbance. After 8 days of treatment and thereafter, significantly more esketamine-treated patients reported improvement in sleep versus antidepressant plus placebo.Keywords: esketamine, treatment-resistant depression, sleep disturbance, insomniaBorentain SWilliamson DTurkoz IPopova VMcCall WVMathews MWiegand FDove Medical Pressarticleesketaminetreatment-resistant depressionsleep disturbanceinsomniaNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 17, Pp 3459-3470 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	esketamine treatment-resistant depression sleep disturbance insomnia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	esketamine treatment-resistant depression sleep disturbance insomnia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Borentain S Williamson D Turkoz I Popova V McCall WV Mathews M Wiegand F Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials
description	Stephane Borentain,1 David Williamson,2,3 Ibrahim Turkoz,4 Vanina Popova,5 William V McCall,3 Maju Mathews,1 Frank Wiegand1 1Department of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA; 2CNS Scientific Affairs Liaisons, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA; 4Department of Clinical Statistics, Janssen Research & Development, LLC, Titusville, NJ, USA; 5Department of Neuroscience Clinical Development, Janssen Research & Development, Beerse, BelgiumCorrespondence: Stephane BorentainDepartment of Global Medical Affairs, Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USATel +1 609-7304420Email SBorent1@ITS.JNJ.comPurpose: To evaluate the relationship of sleep disturbance to the antidepressant effects of esketamine.Materials and Methods: Two double-blind, 4-week studies randomized adults with treatment-resistant depression (TRD) to placebo or esketamine nasal spray, each with newly initiated antidepressant. Sleep was assessed using Montgomery–Åsberg Depression Rating Scale (MADRS) item 4. Change in response (≥ 50% decrease in MADRS total score) and remission (total MADRS score ≤ 12) at day 28 was examined by presence/absence of baseline sleep disturbance using logistic regression models. Impact on reported sleep disturbance (MADRS item 4 score) was examined using ANCOVA models.Results: At baseline, most patients reported disturbed sleep – moderate/severe (65.3%, 369/565), mild (25.3%, 143/565), or none/slightly (9.4%, 53/565) – with similar distribution between treatment groups. A higher proportion of esketamine-treated patients achieved response (OR = 2.05; 95% CI: 1.40– 3.02; P < 0.001) and remission (OR = 1.81; 95% CI: 1.23– 2.66; P = 0.003) at day 28 compared to antidepressant plus placebo, regardless of presence/severity of sleep disturbance. Consistent with this, sleep (MADRS item 4 score) improved in both groups after the first dose, more so with esketamine by day 8 (between-group difference: P ≤ 0.02 at all time points). Across both treatment groups, 1-point improvement in sleep at day 8 increased the probability of antidepressant response on day 28 by 26% (OR = 1.26, 95% CI: 1.12– 1.42; P < 0.001), and remission by 28% (OR = 1.28, 95% CI: 1.14– 1.43; P < 0.001).Conclusion: Antidepressant efficacy of esketamine was demonstrated in patients with TRD, regardless of the presence of sleep disturbance. After 8 days of treatment and thereafter, significantly more esketamine-treated patients reported improvement in sleep versus antidepressant plus placebo.Keywords: esketamine, treatment-resistant depression, sleep disturbance, insomnia
format	article
author	Borentain S Williamson D Turkoz I Popova V McCall WV Mathews M Wiegand F
author_facet	Borentain S Williamson D Turkoz I Popova V McCall WV Mathews M Wiegand F
author_sort	Borentain S
title	Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials
title_short	Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials
title_full	Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials
title_fullStr	Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials
title_full_unstemmed	Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials
title_sort	effect of sleep disturbance on efficacy of esketamine in treatment-resistant depression: findings from randomized controlled trials
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/93725af22f134674b4a3df3ba7a0c03f
work_keys_str_mv	AT borentains effectofsleepdisturbanceonefficacyofesketamineintreatmentresistantdepressionfindingsfromrandomizedcontrolledtrials AT williamsond effectofsleepdisturbanceonefficacyofesketamineintreatmentresistantdepressionfindingsfromrandomizedcontrolledtrials AT turkozi effectofsleepdisturbanceonefficacyofesketamineintreatmentresistantdepressionfindingsfromrandomizedcontrolledtrials AT popovav effectofsleepdisturbanceonefficacyofesketamineintreatmentresistantdepressionfindingsfromrandomizedcontrolledtrials AT mccallwv effectofsleepdisturbanceonefficacyofesketamineintreatmentresistantdepressionfindingsfromrandomizedcontrolledtrials AT mathewsm effectofsleepdisturbanceonefficacyofesketamineintreatmentresistantdepressionfindingsfromrandomizedcontrolledtrials AT wiegandf effectofsleepdisturbanceonefficacyofesketamineintreatmentresistantdepressionfindingsfromrandomizedcontrolledtrials
_version_	1718406340016078848

Effect of Sleep Disturbance on Efficacy of Esketamine in Treatment-Resistant Depression: Findings from Randomized Controlled Trials

Ejemplares similares