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A particularly critical evidence gap exists with respect to whether pharmacological or non-pharmacological augmentation is superior to antidepressant switch, or vice-versa. The objective of this study was to compare the effectiveness of augmentation with aripiprazole or repetitive transcranial magnetic stimulation versus switching to the antidepressant venlafaxine XR (or duloxetine for those not eligible to receive venlafaxine) for treatment-resistant depression. In this multi-site, 8-week, randomized, open-label study, 278 subjects (196 females and 82 males, mean age 45.6 years (SD 15.3)) with treatment-resistant depression were assigned in a 1:1:1 fashion to treatment with either of these three interventions; 235 subjects completed the study. 260 randomized subjects with at least one post-baseline Montgomery-Asberg Depression Rating (MADRS) assessment were included in the analysis. Repetitive transcranial magnetic stimulation (score change (standard error (se))\u2009=\u2009\u221217.39 (1.3) (<jats:italic>p<\/jats:italic>\u2009=\u20090.015) but not aripiprazole augmentation (score change (se)\u2009=\u2009\u221214.9 (1.1) (<jats:italic>p<\/jats:italic>\u2009=\u20090.069) was superior to switch (score change (se)\u2009=\u2009\u221213.22 (1.1)) on the MADRS. Aripiprazole (mean change (se)\u2009=\u2009\u221237.79 (2.9) (<jats:italic>p<\/jats:italic>\u2009=\u20090.003) but not repetitive transcranial magnetic stimulation augmentation (mean change (se)\u2009=\u2009\u221242.96 (3.6) (<jats:italic>p<\/jats:italic>\u2009=\u20090.031) was superior to switch (mean change (se)\u2009=\u2009\u221234.45 (3.0)) on the symptoms of depression questionnaire. Repetitive transcranial magnetic stimulation augmentation was shown to be more effective than switching antidepressants in treatment-resistant depression on the study primary measure. In light of these findings, clinicians should consider repetitive transcranial magnetic stimulation augmentation early-on for treatment-resistant depression.<\/jats:p><jats:p><jats:bold>Trial registration:<\/jats:bold> ClinicalTrials.gov, NCT02977299<\/jats:p>","DOI":"10.1038\/s41380-024-02468-x","type":"journal-article","created":{"date-parts":[[2024,3,7]],"date-time":"2024-03-07T13:04:02Z","timestamp":1709816642000},"page":"2287-2295","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":60,"title":["Comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment resistant depression (ASCERTAIN-TRD) a randomized clinical trial"],"prefix":"10.1038","volume":"29","author":[{"given":"George I.","family":"Papakostas","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2983-1110","authenticated-orcid":false,"given":"Madhukar H.","family":"Trivedi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3806-4208","authenticated-orcid":false,"given":"Richard C.","family":"Shelton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan V.","family":"Iosifescu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael E.","family":"Thase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2764-2391","authenticated-orcid":false,"given":"Manish K.","family":"Jha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2715-6641","authenticated-orcid":false,"given":"Sanjay J.","family":"Mathew","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"DeBattista","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehmet E.","family":"Dokucu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Brawman-Mintzer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glenn W.","family":"Currier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5035-7858","authenticated-orcid":false,"given":"William Vaughn","family":"McCall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mandana","family":"Modirrousta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Macaluso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Bystritsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8273-8820","authenticated-orcid":false,"given":"Fidel Vila","family":"Rodriguez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erik B.","family":"Nelson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albert S.","family":"Yeung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Feeney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie C.","family":"MacGregor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Carmody","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Fava","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,3,7]]},"reference":[{"key":"2468_CR1","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1007\/s40263-012-0031-0","volume":"27","author":"AA Patkar","year":"2013","unstructured":"Patkar AA, Pae CU. 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Lundbeck A\/S, Inflabloc Pharmaceuticals, Janssen Global Services LLC*, Jazz Pharmaceuticals, Johnson & Johnson Companies*, Merck*, Methylation Sciences Inc, Monopteros Therapeutics*, Mylan Inc*, Neurocenria, Novartis Pharma AG, One Carbon Therapeutics, Inc*, Osmotica Pharmaceutical Corp.*, Otsuka Pharmaceuticals, PAMLAB LLC, Pfizer Inc., Pierre Fabre Laboratories, Praxis Precision Medicines*, Ridge Diagnostics (formerly known as Precision Human Biolaboratories), Sage Therapeutics*, Shire Pharmaceuticals, Sunovion Pharmaceuticals, Taisho Pharmaceutical Co, Ltd*, Takeda Pharmaceutical Company LTD, Theracos, Inc., and Wyeth, Inc. GIP has received honoraria (for lectures or consultancy) from Abbott Laboratories, Abbvie, Acadia Pharmaceuticals Inc, Alkermes Inc, Alphasigma USA Inc, Asopharma America Cntral Y Caribe, Astra Zeneca PLC, Avanir Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb Company, Brainsway Ltd, Cephalon Inc., Dey Pharma, L.P., Eli Lilly Co., Evotec AG, Forest Pharmaceuticals, GlaxoSmithKline, Inflabloc Pharmaceuticals, Grunbiotics Pty LTD, Hypera S.A., Jazz Pharmaceuticals, H. Lundbeck A\/S, Medichem Pharmaceuticals, Inc, Meiji Seika Pharma Co. Ltd, Novartis Pharma AG, Otsuka Pharmaceuticals, PAMLAB LLC, Pfizer, Pharma Trade SAS, Pierre Fabre Laboratories, Ridge Diagnostics, Shire Pharmaceuticals, Sunovion Pharmaceuticals, Takeda Pharmaceutical Company LTD, Theracos, Inc., Titan Pharmaceuticals, and Wyeth Inc. GIP has received research support (paid to hospital) from Alphasigma USA, Inc, AstraZeneca PLC, Beckley Psytech, Bristol-Myers Squibb Company, Cala Health, Forest Pharmaceuticals, the National Institute of Mental Health, Mylan Inc, Neuralstem, Inc*, PAMLAB LLC, PCORI, Pfizer Inc., Johnson & Johnson Companies, Ridge Diagnostics (formerly known as Precision Human Biolaboratories), Sunovion Pharmaceuticals, Tal Medical, and Theracos, Inc. GIP has served (not currently) on the speaker\u2019s bureau for BristolMyersSquibb Co and Pfizer, Inc.* Asterisk denotes consulting activity undertaken on behalf of Massachusetts General Hospital. MHT has provided consulting services to ACADIA Pharmaceuticals, Akili Interactive, Allergan, Alkermes Inc., Alto Neuroscience Inc, Applied Clinical Intelligence, LLC, Axsome Therapeutics, Biogen MA Inc, Boegringer Ingelheim, Cerebral Inc., Circular Genomics Inc., Compass Pathfinder Limited, GH Research, GreenLight VitalSign6 Inc, Global Medical Education, Heading Health, Health Care Global Village, Janssen Pharmaceutical, Jazz Pharmaceutical, Legion Health, Lilly USA, Lundbeck Research USA, Medavante, Medscape LLC, Merck Sharp & Dohme Corp., Mind Medicine Inc., Mitsubishi Tanabe Pharma Development America, Myriad Neuroscience, Naki Health Ltd, Navitor, Neurocrine Biosciences Inc., Neuronetics, Noema Pharma AG, Orexo US Inc., Otsuka America Pharmaceutical Inc, Pamlab, Perception Neuroscience Holdings, Pfizer, PGxHealth, Pharmerit International, Phoenix Marketing Solutions, Policy Analysis Inc., Praxis Precision Medicines Inc, Rexahn Pharmaceuticals, Ridge Diagnostics, Roche TCRC, SAGE Therapeutics, Shire US, Signant Health, SK Life, Sparian Biosciences, Sunovian Pharmaceuticals, Tal Medical, Targacept, The Baldwin Group, Titan Pharmaceuticals, Takeda Pharmaceuticals Inc, WebMD. He has received grant\/research funding from NIMH, NIDA, NCATS, American Foundation for Suicide Prevention, Patient-Centered Outcomes Research Institute (PCORI), and Blue Cross Blue Shield of Texas. Additionally, he has received editorial compensation from Engage Health Media, and Oxford University Press. RCS: Research Support: NIH, PCORI, American Foundation for Suicide Prevention, Acadia Pharmaceuticals, Alkermes, Inc., Allergan, Plc, Alto Pharmaceuticals, Avanir Pharmaceuticals, Inc., Boehringer Ingelheim, Denovo Biopharma, Genomind, InMune Bio, Intra-cellular Therapies, Janssen Pharmaceuticals, LivaNova PLC, Navitor Pharmaceuticals, Neurocrine Biosciences, Neurorx, Novartis Pharmaceuticals, Otsuka Pharmacetical Company, Sunovion Pharmaceuticals, Takeda Pharmaceuticals. Consulting: Acadia Pharmaceuticals, Allergan, Plc, Alphasigma USA, Inc., Boehringer Ingelheim, Cerecor, Inc., Denovo Biopharma, Janssen Pharmaceuticals, Myriad Neuroscience, Neurorx, Novartis AG, Otsuka Pharmaceuticals, Seelos Therapeutics, Inc., Sunovion Pharmaceuticals, Takeda Pharmaceuticals. DVI: In the last ten years, DVI has received consulting honoraria from Alkermes, Allergan, Axsome, Biogen, Boehringer Ingelheim, Centers for Psychiatric Excellence, Clexio, Jazz, Lundbeck, Otsuka, Precision Neuroscience, Relmada, Sage, Sunovion; he has received research support (through his academic institutions) from Alkermes, Astra Zeneca, Brainsway, Litecure, Neosync, Otsuka, Roche, Shire. MET: Disclosure Information (Past 24 Months) Grant Support: Acadia, Inc.; Allergan, Inc.; AssureRx Health; Axsome Therapeutics Inc.; BioHaven, Inc.; Intracellular, Inc.; Johnson & Johnson; Otsuka Pharmaceutical Company, Ltd.; Patient-Centered Outcomes Research Institute (PCORI); Takeda Pharmaceutical Company, Ltd. Advisory\/Consultant: Acadia, Inc.; Akili, Inc.; Alkermes PLC; Allergan, Inc.; Axsome Therapeutics, Inc.; BioHaven, Inc.; Bocemtium Consulting, S.L.; Boehringer Ingelheim International; CatalYm GmbH; Clexio Biosciences; Gerson Lehrman Group, Inc.; H. Lundbeck, A\/S; Jazz Pharmaceuticals; Janssen; Johnson & Johnson; Luye Pharma Group, Ltd.; Merck & Company, Inc.; Otsuka Pharmaceutical Company, Ltd.; Pfizer, Inc.; Sage Pharmaceuticals; Seelos Pharmaceuticals; Sunovion Pharmaceuticals, Inc.; Takeda Pharmaceutical Company, Ltd. CE Speakers Bureau: None. Stockholder (privately held): None. Stockholder (publicly traded): None. Royalties: American Psychiatric Foundation; Guilford Publications; Herald House; Kluwer-Wolters; W.W. Norton & Company, Inc. Spouse\u2019s Employment: Peloton Advantage, which does business with most major pharmaceutical companies. MKJ: Lifetime (same as 36 months). MKJ has received contract research grants from Acadia Pharmaceuticals, Neurocrine Bioscience, Navitor\/Supernus and Janssen Research & Development, educational grant to serve as Section Editor of the Psychiatry & Behavioral Health Learning Network, consultant fees from Eleusis Therapeutics US, Inc, Janssen Global Services, Janssen Scientific Affairs, Worldwide Clinical Trials\/Eliem and Inversargo, and Guidepoint Global, and honoraria from North American Center for Continuing Medical Education, Medscape\/WebMD, Clinical Care Options, and Global Medical Education. 12 Months. MKJ has received contract research grants from Neurocrine Bioscience, Navitor\/Supernus and Janssen Research & Development, educational grant to serve as Section Editor of the Psychiatry & Behavioral Health Learning Network, consultant fees from Eleusis Therapeutics US, Inc, Janssen Global Services, Janssen Scientific Affairs, Worldwide Clinical Trials\/Eliem, and Guidepoint Global, and honoraria from North American Center for Continuing Medical Education, Medscape\/WebMD, Clinical Care Options, and Global Medical Education. SJM is supported through the use of resources and facilities at the Michael E. Debakey VA Medical Center, Houston, Texas and receives support from The Menninger Clinic. SJM has served as a consultant to Allergan, Alkermes, Almatica Pharma, Axsome Therapeutics, BioXcel Therapeutics, Clexio Biosciences, COMPASS Pathways, Eleusis, EMA Wellness, Engrail Therapeutics, Greenwich Biosciences, Intra-Cellular Therapies, Janssen, Levo Therapeutics, Perception Neurosciences, Praxis Precision Medicines, Neumora, Neurocrine, Relmada Therapeutics, Sage Therapeutics, Seelos Therapeutics, Signant Health, Sunovion and Worldwide Clinical Trials. He has received research support from Biohaven Pharmaceuticals, Boehringer-Ingelheim, Janssen, Merck, Sage Therapeutics, and VistaGen Therapeutics. CDB: Grant support: Compass, Otsuka, Beckley, Relmada, Janssen, Sage. Consultant: Corcept, Sage, Alkermes, Pfizer, AbbVie, MED: In 2008, MED received a one-time consulting honorarium from Neuronetics Inc. In 2012, MED attended a speaker training symposium invited and organized by Neuronetics. Inc but has not participated in any speaker bureau activities. From 2015\u20132021, Neuronetics Inc. donated TMS treatment supplies to a Northwestern University funded clinical TMS trial for cancer survivors (25 patients) in which MED was the principal investigator. OB-M: Lifetime. OB-M has received contract research grants from AgeneBio, Pfizer, Green Valley Pharmaceuticals, Avanir, Axsome therapeutics, Takeda, DoD CDMRP, VA HSR&D, USC ATRI (NIA\/NIH), UCSD ADCS (NIA\/NIH), Lundbeck, Janssen, Shire pharmaceuticals, Eli Lilly, Biovail, UCB Pharma, Bristol-Meyers Squibb, Sanofi Aventis, AstraZeneca, Forest pharmaceuticals, Novartis, Merk, Bristol-Meyers Squibb, Wyeth-Ayerst. Consultant fees Janssen, Pfizer, AstraZeneca, Forest. Speaker\u2019s Bureaus for Pfizer, Janssen, AstraZeneca, Forest. 12 Months. OB-M has received research grants from AgeneBio, Green Valley Pharmaceuticals, Avanir, DoDCDMRP, VA HSR&D, USC ATRI (NIA\/NIH), UCSD ADCS (NIA\/NIH), Axsome Therapeutics. GWC: none. WVM: Lifetime. WVM has received contract research grants from Vistagen, Merck, MECTA, Neurosync, Cephalon, Corcept, Sealy, Sanofi, Bristol-Meyers Squibb, Glaxo, Somaxon, Neuronetics, Cephalon, Sepracor, Takeda, Searle, and Wyeth-Ayerst. Consultant fees from Idorsia, and royalties from Wolters Kluwer. Speaker\u2019s Bureaus for Pfizer, Wyeth-Ayerst, Sepracor, GSK 12 Months. WVM has received contract research grants from Vistagen, consultant fees from Idorsia, and roylaties from Wolters Kluwer. MModirrousta: none. MMacaluso: D.O. has conducted clinical trials research as principal investigator for the following pharmaceutical companies over the last twelve months: 1. AssureRx\/Myriad 2. Avanir 3. Boehringer-Ingelheim 4. Electrocore 5. Janssen 6. Liva Nova 7. Merck 8. Neurocrine 9. Novartis 10. Otsuka All clinical trial and study contracts were with and payments made to the University of Alabama at Birmingham. From April 2019 to June of 2020, Dr Macaluso was a member of the speaker bureau for Janssen pharmaceuticals (Spravato\/esketamine). MMacaluso serves as a consultant for Nusachi labs and PharmaTher. MMacaluso has received royalties from Springer Nature for textbooks published. AB has previously received grant support from BMS, Wyeth and Brainsway. FVR receives research support from CIHR, Brain Canada, Michael Smith Foundation for Health Research, Vancouver Coastal Health Research Institute, and Weston Brain Institute for investigator-initiated research. Philanthropic support from Seedlings Foundation. In-kind equipment support for this investigator-initiated trial from MagVenture. He has received honoraria for participation in an advisory board for Allergan. EBN: none. ASY: none. AF: None. LCM: None. TC has been a consultant for Alkermes. MF: Reports 3-year disclosures as below - Research Support: Acadia Pharmaceuticals; Aditum Bio Management Company, LLC; Allergan, Alkermes, Inc.; Altimate Health Corporation; Alto Neuroscience, Inc.; Ancora Bio, Inc.; Angelini S.p.A; Aptinyx; Arbor Pharmaceuticals LLC; Avanir Pharmaceuticals Inc.; Axsome; Benckiser Pharmaceuticals, Inc.; BioClinica, Inc.; Biogen; BioHaven; BioShin Limited; Cambridge Science Corporation; Centrexion Therapeutics Corporation; Cerecor; Cybin IRL Limited; Eliem Therapeutics LTD; Gate Neurosciences, Inc.; GenOmind, LLC; Gentelon, LLC; Happify; Johnson & Johnson; Lundbeck Inc.; Marinus Pharmaceuticals; Methylation Sciences, Inc.; Millennium Pharmaceutics, Inc.; Minerva Neurosciences; Neuralstem; Neurocrine Biosciences, Inc.; NeuroRX Inc.; Novaremed; Novartis; Otsuka; Pfizer; Premiere Research International; Praxis Precision Medicines; Protagenic Therapeutics, Inc.; Relmada Therapeutics. Inc.; Reckitt; Shenox Pharmaceuticals; Stanley Medical Research Institute (SMRI); Taisho; Takeda; University of Michigan; Vistagen; WinSanTor, Inc.; Xenon Pharmaceuticals, Inc.; National Institute of Drug Abuse (NIDA); National Institutes of Health (NIH); National Institute of Mental Health (NIMH); and PCORI. MF has not done any personal consulting. Any consulting he has done has been on behalf of Massachusetts General Hospital, except for Sensorium Therapeutics. Speaking\/Publishing: Lecture given at Global Medical Education, Inc. Mood Disorders Summit, November 2020. Stock\/Other Financial Options: Equity Holdings: Compellis; Neuromity; Psy Therapeutics; Sensorium Therapeutics Royalty\/patent, other income: Patents for Sequential Parallel Comparison Design (SPCD), licensed by MGH to Pharmaceutical Product Development, LLC (PPD) (US_7840419, US_7647235, US_7983936, US_8145504, US_8145505); and patent application for a combination of Ketamine plus Scopolamine in Major Depressive Disorder (MDD), licensed by MGH to Biohaven. Patents for pharmacogenomics of Depression Treatment with Folate (US_9546401, US_9540691). Copyright for the MGH Cognitive & Physical Functioning Questionnaire (CPFQ), Sexual Functioning Inventory (SFI), Antidepressant Treatment Response Questionnaire (ATRQ), Discontinuation-Emergent Signs & Symptoms (DESS), Symptoms of Depression Questionnaire (SDQ), and SAFER; Belvior; Lippincott, Williams & Wilkins; Wolkers Kluwer; World Scientific Publishing Co. Pte.Ltd. **All lifetime disclosures can be viewed online by navigating to:  >MF, MD>View Bio>View Disclosures Here.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}