Clotilde Guidetti, Stefania Chaikali, Madhukar H Trivedi, Richard C Shelton, Dan V Iosifescu, Michael E Thase, Manish K Jha, Sanjay H Mathew, Charles DeBattista, Mehmet E Dokucu, Olga Brawman-Mintzer, Jesús Manuel Hernández Ortiz, Glenn W Currier, William Vaughn McCall, Mandana Modirrousta, Matthew Macaluso, Alexander Bystritsky, Fidel Vila-Rodriguez, Erik B Nelson, Albert S Yeung, Leslie C MacGregor, Thomas Carmody, Maurizio Fava, George I Papakostas
{"title":"抗抑郁药不完全和无反应治疗难治性抑郁症（确定- trd）的比较疗效研究试验：阿立哌唑或重复经颅磁刺激增强与切换到抗抑郁药文拉法辛对生活质量的影响。","authors":"Clotilde Guidetti, Stefania Chaikali, Madhukar H Trivedi, Richard C Shelton, Dan V Iosifescu, Michael E Thase, Manish K Jha, Sanjay H Mathew, Charles DeBattista, Mehmet E Dokucu, Olga Brawman-Mintzer, Jesús Manuel Hernández Ortiz, Glenn W Currier, William Vaughn McCall, Mandana Modirrousta, Matthew Macaluso, Alexander Bystritsky, Fidel Vila-Rodriguez, Erik B Nelson, Albert S Yeung, Leslie C MacGregor, Thomas Carmody, Maurizio Fava, George I Papakostas","doi":"10.4088/JCP.24m15614","DOIUrl":null,"url":null,"abstract":"<p><p><b>Objective:</b> This study compared the effects of augmenting antidepressants with aripiprazole or repetitive transcranial magnetic stimulation (rTMS) versus switching to venlafaxine XR/duloxetine on quality of life (QoL) among patients with treatment resistant depression (TRD).</p><p><p><b>Methods:</b> In a predefined secondary analysis of a multisite, open-label, effectiveness trial, patients with TRD were randomly assigned to aripiprazole augmentation, rTMS augmentation, or switching to venlafaxine XR/duloxetine in a 1:1:1 ratio, and they were treated for 8 weeks. TRD was defined as an inadequate response to 2 or more antidepressant trials of adequate dose and duration, as defined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire. QoL was predefined as a key secondary end point for this study and assessed using the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). A mixed-effects model with repeated measures was applied. This study was conducted from July 13, 2017, to December 22, 2021.</p><p><p><b>Results:</b> Among 258 randomized participants with at least 1 postbaseline Q-LES-Q-SF measurement, augmentation with aripiprazole demonstrated statistically significant superiority over switching on the Q-LES-Q-SF (<i>P</i>=.002), while rTMS did not (<i>P</i>=.326). At end point, changes from baseline in the Q-LES-Q-SF scores were 10.61 (SE=1.0) for aripiprazole augmentation, 11.59 (SE=1.1) for rTMS augmentation, and 8.68 (SE=0.9) for venlafaxine XR/duloxetine switch.</p><p><p><b>Conclusion:</b> Augmentation with aripiprazole, but not rTMS, improved QoL significantly versus venlafaxine XR/duloxetine switch in TRD patients. However, a much smaller than expected sample size for the rTMS group may explain the lack of statistical significance rendering the latter finding of indeterminate nature.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT02977299.</p>","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"86 3","pages":""},"PeriodicalIF":4.6000,"publicationDate":"2025-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative Effectiveness Research Trial for Antidepressant Incomplete and Nonresponders With Treatment Resistant Depression (ASCERTAIN-TRD): Effect of Aripiprazole or Repetitive Transcranial Magnetic Stimulation Augmentation Versus Switching to the Antidepressant Venlafaxine on Quality of Life.\",\"authors\":\"Clotilde Guidetti, Stefania Chaikali, Madhukar H Trivedi, Richard C Shelton, Dan V Iosifescu, Michael E Thase, Manish K Jha, Sanjay H Mathew, Charles DeBattista, Mehmet E Dokucu, Olga Brawman-Mintzer, Jesús Manuel Hernández Ortiz, Glenn W Currier, William Vaughn McCall, Mandana Modirrousta, Matthew Macaluso, Alexander Bystritsky, Fidel Vila-Rodriguez, Erik B Nelson, Albert S Yeung, Leslie C MacGregor, Thomas Carmody, Maurizio Fava, George I Papakostas\",\"doi\":\"10.4088/JCP.24m15614\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Objective:</b> This study compared the effects of augmenting antidepressants with aripiprazole or repetitive transcranial magnetic stimulation (rTMS) versus switching to venlafaxine XR/duloxetine on quality of life (QoL) among patients with treatment resistant depression (TRD).</p><p><p><b>Methods:</b> In a predefined secondary analysis of a multisite, open-label, effectiveness trial, patients with TRD were randomly assigned to aripiprazole augmentation, rTMS augmentation, or switching to venlafaxine XR/duloxetine in a 1:1:1 ratio, and they were treated for 8 weeks. TRD was defined as an inadequate response to 2 or more antidepressant trials of adequate dose and duration, as defined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire. QoL was predefined as a key secondary end point for this study and assessed using the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). A mixed-effects model with repeated measures was applied. This study was conducted from July 13, 2017, to December 22, 2021.</p><p><p><b>Results:</b> Among 258 randomized participants with at least 1 postbaseline Q-LES-Q-SF measurement, augmentation with aripiprazole demonstrated statistically significant superiority over switching on the Q-LES-Q-SF (<i>P</i>=.002), while rTMS did not (<i>P</i>=.326). At end point, changes from baseline in the Q-LES-Q-SF scores were 10.61 (SE=1.0) for aripiprazole augmentation, 11.59 (SE=1.1) for rTMS augmentation, and 8.68 (SE=0.9) for venlafaxine XR/duloxetine switch.</p><p><p><b>Conclusion:</b> Augmentation with aripiprazole, but not rTMS, improved QoL significantly versus venlafaxine XR/duloxetine switch in TRD patients. However, a much smaller than expected sample size for the rTMS group may explain the lack of statistical significance rendering the latter finding of indeterminate nature.</p><p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT02977299.</p>\",\"PeriodicalId\":50234,\"journal\":{\"name\":\"Journal of Clinical Psychiatry\",\"volume\":\"86 3\",\"pages\":\"\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2025-08-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Psychiatry\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4088/JCP.24m15614\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PSYCHIATRY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4088/JCP.24m15614","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHIATRY","Score":null,"Total":0}
Comparative Effectiveness Research Trial for Antidepressant Incomplete and Nonresponders With Treatment Resistant Depression (ASCERTAIN-TRD): Effect of Aripiprazole or Repetitive Transcranial Magnetic Stimulation Augmentation Versus Switching to the Antidepressant Venlafaxine on Quality of Life.
Objective: This study compared the effects of augmenting antidepressants with aripiprazole or repetitive transcranial magnetic stimulation (rTMS) versus switching to venlafaxine XR/duloxetine on quality of life (QoL) among patients with treatment resistant depression (TRD).
Methods: In a predefined secondary analysis of a multisite, open-label, effectiveness trial, patients with TRD were randomly assigned to aripiprazole augmentation, rTMS augmentation, or switching to venlafaxine XR/duloxetine in a 1:1:1 ratio, and they were treated for 8 weeks. TRD was defined as an inadequate response to 2 or more antidepressant trials of adequate dose and duration, as defined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire. QoL was predefined as a key secondary end point for this study and assessed using the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). A mixed-effects model with repeated measures was applied. This study was conducted from July 13, 2017, to December 22, 2021.
Results: Among 258 randomized participants with at least 1 postbaseline Q-LES-Q-SF measurement, augmentation with aripiprazole demonstrated statistically significant superiority over switching on the Q-LES-Q-SF (P=.002), while rTMS did not (P=.326). At end point, changes from baseline in the Q-LES-Q-SF scores were 10.61 (SE=1.0) for aripiprazole augmentation, 11.59 (SE=1.1) for rTMS augmentation, and 8.68 (SE=0.9) for venlafaxine XR/duloxetine switch.
Conclusion: Augmentation with aripiprazole, but not rTMS, improved QoL significantly versus venlafaxine XR/duloxetine switch in TRD patients. However, a much smaller than expected sample size for the rTMS group may explain the lack of statistical significance rendering the latter finding of indeterminate nature.
期刊介绍：
For over 75 years, The Journal of Clinical Psychiatry has been a leading source of peer-reviewed articles offering the latest information on mental health topics to psychiatrists and other medical professionals.The Journal of Clinical Psychiatry is the leading psychiatric resource for clinical information and covers disorders including depression, bipolar disorder, schizophrenia, anxiety, addiction, posttraumatic stress disorder, and attention-deficit/hyperactivity disorder while exploring the newest advances in diagnosis and treatment.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
