Jennifer Kern Sliwa, Ronaldo R Naranjo, Ibrahim Turkoz, Mary Pat Petrillo, Patricia Cabrera, Madhukar Trivedi
{"title":"艾司氯胺酮鼻喷雾剂对成人耐药性抑郁症患者抑郁症状严重程度的影响，以及蒙哥马利-奥斯伯格抑郁评分量表和 9 项患者健康问卷之间的关联。","authors":"Jennifer Kern Sliwa, Ronaldo R Naranjo, Ibrahim Turkoz, Mary Pat Petrillo, Patricia Cabrera, Madhukar Trivedi","doi":"10.1017/S1092852924000105","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To examine the effect of esketamine nasal spray (ESK) plus newly initiated oral antidepressant (OAD) versus OAD plus placebo nasal spray (PBO) on the association between Montgomery-Åsberg Depression Rating Scale (MADRS) and 9-item Patient Health Questionnaire (PHQ-9) scores in adults with treatment-resistant depression (TRD).</p><p><strong>Methods: </strong>Data from TRANSFORM-1 and TRANSFORM-2 (two similarly designed, randomized, active-controlled TRD studies) and SUSTAIN-1 (relapse prevention study) were analyzed. Group differences for mean changes in PHQ-9 total score from baseline were compared using analysis of covariance. Associations between MADRS and PHQ-9 total scores from TRANSFORM-1/TRANSFORM-2 were assessed using simple parametric, nonparametric, and multiple regression models.</p><p><strong>Results: </strong>In TRANSFORM-1/TRANSFORM-2 (ESK + OAD, <i>n</i> = 343; OAD + PBO, <i>n</i> = 222), baseline PHQ-9 mean scores were 20.4 for ESK + OAD and 20.6 for OAD + PBO (severe depression). At day 28, significant group differences were observed in least squares mean change (SE) in PHQ-9 scores from baseline (-12.8 [0.46] vs -10.3 [0.53], <i>P</i> < .001) and in clinically substantial change in PHQ-9 scores (≥6 points; 77.1% vs 64%, <i>P</i> < .001) in ESK + OAD and OAD + PBO groups, respectively. A nonlinear relationship between MADRS and PHQ-9 was observed; total scores demonstrated increased correlation over time. In SUSTAIN-1, 57.3% of patients receiving ESK + OAD (<i>n</i> = 89) versus 44.2% receiving OAD + PBO (<i>n</i> = 86) retained remission status (PHQ-9 score ≤4) at maintenance treatment end point (<i>P =</i> .044).</p><p><strong>Conclusions: </strong>In adults with TRD, ESK + OAD significantly improved severity of depressive symptoms, and more patients achieved clinically meaningful changes in depressive symptoms based on PHQ-9, versus OAD + PBO. PHQ-9 outcomes were consistent with those of clinician-rated MADRS.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT02417064, NCT02418585, NCT02493868.</p>","PeriodicalId":10505,"journal":{"name":"CNS Spectrums","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of esketamine nasal spray on depressive symptom severity in adults with treatment-resistant depression and associations between the Montgomery-Åsberg Depression Rating Scale and the 9-item Patient Health Questionnaire.\",\"authors\":\"Jennifer Kern Sliwa, Ronaldo R Naranjo, Ibrahim Turkoz, Mary Pat Petrillo, Patricia Cabrera, Madhukar Trivedi\",\"doi\":\"10.1017/S1092852924000105\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To examine the effect of esketamine nasal spray (ESK) plus newly initiated oral antidepressant (OAD) versus OAD plus placebo nasal spray (PBO) on the association between Montgomery-Åsberg Depression Rating Scale (MADRS) and 9-item Patient Health Questionnaire (PHQ-9) scores in adults with treatment-resistant depression (TRD).</p><p><strong>Methods: </strong>Data from TRANSFORM-1 and TRANSFORM-2 (two similarly designed, randomized, active-controlled TRD studies) and SUSTAIN-1 (relapse prevention study) were analyzed. Group differences for mean changes in PHQ-9 total score from baseline were compared using analysis of covariance. Associations between MADRS and PHQ-9 total scores from TRANSFORM-1/TRANSFORM-2 were assessed using simple parametric, nonparametric, and multiple regression models.</p><p><strong>Results: </strong>In TRANSFORM-1/TRANSFORM-2 (ESK + OAD, <i>n</i> = 343; OAD + PBO, <i>n</i> = 222), baseline PHQ-9 mean scores were 20.4 for ESK + OAD and 20.6 for OAD + PBO (severe depression). At day 28, significant group differences were observed in least squares mean change (SE) in PHQ-9 scores from baseline (-12.8 [0.46] vs -10.3 [0.53], <i>P</i> < .001) and in clinically substantial change in PHQ-9 scores (≥6 points; 77.1% vs 64%, <i>P</i> < .001) in ESK + OAD and OAD + PBO groups, respectively. A nonlinear relationship between MADRS and PHQ-9 was observed; total scores demonstrated increased correlation over time. In SUSTAIN-1, 57.3% of patients receiving ESK + OAD (<i>n</i> = 89) versus 44.2% receiving OAD + PBO (<i>n</i> = 86) retained remission status (PHQ-9 score ≤4) at maintenance treatment end point (<i>P =</i> .044).</p><p><strong>Conclusions: </strong>In adults with TRD, ESK + OAD significantly improved severity of depressive symptoms, and more patients achieved clinically meaningful changes in depressive symptoms based on PHQ-9, versus OAD + PBO. PHQ-9 outcomes were consistent with those of clinician-rated MADRS.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT02417064, NCT02418585, NCT02493868.</p>\",\"PeriodicalId\":10505,\"journal\":{\"name\":\"CNS Spectrums\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CNS Spectrums\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1017/S1092852924000105\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/4/1 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CNS Spectrums","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1017/S1092852924000105","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/4/1 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Effects of esketamine nasal spray on depressive symptom severity in adults with treatment-resistant depression and associations between the Montgomery-Åsberg Depression Rating Scale and the 9-item Patient Health Questionnaire.
Objective: To examine the effect of esketamine nasal spray (ESK) plus newly initiated oral antidepressant (OAD) versus OAD plus placebo nasal spray (PBO) on the association between Montgomery-Åsberg Depression Rating Scale (MADRS) and 9-item Patient Health Questionnaire (PHQ-9) scores in adults with treatment-resistant depression (TRD).
Methods: Data from TRANSFORM-1 and TRANSFORM-2 (two similarly designed, randomized, active-controlled TRD studies) and SUSTAIN-1 (relapse prevention study) were analyzed. Group differences for mean changes in PHQ-9 total score from baseline were compared using analysis of covariance. Associations between MADRS and PHQ-9 total scores from TRANSFORM-1/TRANSFORM-2 were assessed using simple parametric, nonparametric, and multiple regression models.
Results: In TRANSFORM-1/TRANSFORM-2 (ESK + OAD, n = 343; OAD + PBO, n = 222), baseline PHQ-9 mean scores were 20.4 for ESK + OAD and 20.6 for OAD + PBO (severe depression). At day 28, significant group differences were observed in least squares mean change (SE) in PHQ-9 scores from baseline (-12.8 [0.46] vs -10.3 [0.53], P < .001) and in clinically substantial change in PHQ-9 scores (≥6 points; 77.1% vs 64%, P < .001) in ESK + OAD and OAD + PBO groups, respectively. A nonlinear relationship between MADRS and PHQ-9 was observed; total scores demonstrated increased correlation over time. In SUSTAIN-1, 57.3% of patients receiving ESK + OAD (n = 89) versus 44.2% receiving OAD + PBO (n = 86) retained remission status (PHQ-9 score ≤4) at maintenance treatment end point (P = .044).
Conclusions: In adults with TRD, ESK + OAD significantly improved severity of depressive symptoms, and more patients achieved clinically meaningful changes in depressive symptoms based on PHQ-9, versus OAD + PBO. PHQ-9 outcomes were consistent with those of clinician-rated MADRS.
期刊介绍：
CNS Spectrums covers all aspects of the clinical neurosciences, neurotherapeutics, and neuropsychopharmacology, particularly those pertinent to the clinician and clinical investigator. The journal features focused, in-depth reviews, perspectives, and original research articles. New therapeutics of all types in psychiatry, mental health, and neurology are emphasized, especially first in man studies, proof of concept studies, and translational basic neuroscience studies. Subject coverage spans the full spectrum of neuropsychiatry, focusing on those crossing traditional boundaries between neurology and psychiatry.
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