LS contributed to the study design, assisted with study coordination, oversaw the analyses, and wrote the manuscript. RM assisted in planning the data analyses and writing the manuscript. TD assisted with conducting the study, overseeing the study analyses, and writing the manuscript. MT assisted with conducting the study and writing the manuscript. NRH assisted with conducting the study and writing the manuscript. MM assisted with conducting the study and writing the manuscript. JK assisted with conducting the study and writing the manuscript. CB assisted with conducting the study and writing the manuscript. JC assisted with conducting the study and writing the manuscript. KG assisted with conducting the study and writing the manuscript. TK assisted with conducting the study and writing the manuscript. RS assisted with conducting the study and writing the manuscript. SM assisted with conducting the study and writing the manuscript. EF assisted with conducting the study and writing the manuscript. DR conducted the statistical analyses and assisted in writing the manuscript. AN conceived of the study, and participated in its design and coordination and helped to draft the manuscript. All authors read and approved the final manuscript.
Acknowledgements
This study was funded by the Agency of Healthcare Research and Quality (AHRQ) Grant R01 HS019371-01
Competing interests
Dr. Sylvia was a shareholder in Concordant Rater Systems and serves as a consultant for United Biosource Corporation and Clintara. She receives royalties from New Harbinger. Ms. Montana reports no competing interests. Dr. Deckersbach’s research has been funded by NIH, NIMH, NARSAD, TSA, IOCDF, Tufts University, DBDAT, Otsuka Pharmaceuticals and Cogito, Inc. He has received honoraria, consultation fees and/or royalties from the MGH Psychiatry Academy, BrainCells Inc., Clintara, LLC., Systems Research and Applications Corporation, Boston University, the Catalan Agency for Health Technology Assessment and Research, the National Association of Social Workers Massachusetts, the Massachusetts Medical Society, Tufts University, NIDA, NIMH, and the Oxford University Press. He has also participated in research funded by DARPA, NIH, NIMH, NIA, AHRQ, PCORI, Janssen Pharmaceuticals, The Forest Research Institute, Shire Development Inc., Medtronic, Cyberonics, Northstar, Takeda, and Sunovion. Dr. Thase has been an advisor/consultant: Alkermes; Allergan; AstraZeneca; Bristol-Myers Squibb Company; Cerecor, Inc.; Eli Lilly & Co.; Fabre-Kramer Pharmaceuticals, Inc.; Forest Laboratories; Gerson Lehrman Group; GlaxoSmithKline; Guidepoint Global; H. Lundbeck A/S; MedAvante, Inc.; Merck and Co. Inc. (formerly Schering Plough and Organon); Moksha8; Naurex, Inc.; Neuronetics, Inc.; Novartis; Ortho-McNeil Pharmaceuticals (Johnson & Johnson; Janssen); Otsuka; Pamlab, L.L.C. (Nestle); Pfizer (formerly Wyeth Ayerst Pharmaceuticals); Shire US Inc.; Sunovion Pharmaceuticals, Inc.; .; Takeda; and Trius Therapeutical, Inc. Dr. Thase receives grant funding from the Agency for Healthcare Research and Quality; Alkermes; AssureRx; Avanir; Forest Pharmaceuticals; Janssen; National Institute of Mental Health; Otsuka Pharmaceuticals. He has equity holdings in MedAvante, Inc. and receives royalty income from American Psychiatric Foundation, Inc., Guilford Publications, Herald House, the Oxford University Press, and W.W. Norton & Company. His wife is employed as the Group Scientific Director for Peloton Advantage which does business with Pfizer. Dr. Tohen was an employee of Lilly (1997 to 2008) and has received honoraria from or consulted for Abbott, AstraZeneca, Alkermes, Bristol Myers Squibb, GlaxoSmithKline, Lilly, Johnson & Johnson, Otsuka, Merck, Sunovion, Forest, Roche, Elan, Lundbeck, Teva, Pamlab, Minerva, Pfizer, Wyeth and Wiley Publishing; his spouse was a full time employee at Lilly (1998–2013). Dr. Reilly-Harrington receives royalties from the Oxford University Press, the American Psychological Association, and New Harbinger. She serves as a consultant for United Biosource Corporation and was a shareholder in Concordant Rater Systems. Dr. McInnis has received grants for research support from NIMH, the Heinz C Prechter Research Fund, and the Michigan Institute for Clinical Health Research (MICHR). MM has received consulting income from the Qatar National Research Foundation, Janssen, and Merck Pharmaceuticals. Dr. Kocsis has received research grants and contracts from AHRQ, NIMH, Pritzker Consortium, Qatar National Research Fund, and Rockefeller Treatment Development Fund. He holds an Elan. Patent (No. 8,853,279), entitled “Method for Determining Sensitivity or Resistance to Compounds That Activate the Brain Serotonin System.” Dr. Bowden is conducting a biological study in mood disorders sponsored by Myriad Inc. He has no competing interests. Dr. Calabrese has received federal funding from the Department of Defense, Health Resources Services Administration and National Institute of Mental Health as well as grant support from: Abbott Laboratories; AstraZeneca; Bristol-Myers Squibb Company; Cephalon, Inc. (now Teva Pharmaceutical Industries Ltd.); Dainippon Sumitomo Pharma Co., Ltd.; GlaxoSmithKline; Janssen Pharmaceuticals, Inc.; Eli Lilly and Company; Intra-Cellular Therapies, Inc.; Pfizer, Inc; H. Lundbeck A/S; Sunovion Pharmaceuticals Inc.; Takeda Pharmaceutical Company Limited. Dr. Calabrese has served as a consultant/advisory board member/speaker for: Abbott Laboratories; Allergan; AstraZeneca; Bristol-Myers Squibb Company; Cephalon, Inc. (now Teva Pharmaceutical Industries Ltd.); Dainippon Sumitomo Pharma Co., Ltd.; GlaxoSmithKline; Janssen Pharmaceuticals, Inc.; H. Lundbeck A/S,;Merck & Co., Inc.; Otsuka Pharmaceutical Co., Ltd.; Pfizer, Inc; Repligen Corporation; Servier; Sunovion Pharmaceuticals Inc.; Solvay Pharmaceuticals, Inc.; Takeda Pharmaceutical Company Limited. Dr. Gao has been on a speaker’s bureau of Sunovion and was on an advisory aboard of Sunovion. He received grant support from AstraZeneca, Brain and Behavior Research Foundation, and Cleveland Foundation. Dr. Ketter has the following financial interests/arrangements or affiliations that could be perceived as real or apparent conflicts of interest: Grant/Research Support from the AstraZeneca Pharmaceuticals LP, Cephalon Inc., Eli Lilly and Company, Pfizer Inc., and Sunovion Pharmaceuticals; Consultant Fees from Allergan, Inc., Avanir Pharmaceuticals, Bristol-Myers Squibb Company, Cephalon Inc., Forest Pharmaceuticals, Janssen Pharmaceutica Products, LP, Merck & Co., Inc., Sunovion Pharmaceuticals, Teva Pharmaceuticals; Lecture Honoraria from Abbott Laboratories, Inc., AstraZeneca Pharmaceuticals LP, GlaxoSmithKline, and Otsuka Pharmaceuticals; and Publication Royalties from American Psychiatric Publishing, Inc. In addition, Dr. Ketter’s spouse is an employee of and holds stock in Janssen Pharmaceuticals. Dr. Shelton has been a consultant for: Allergan, Inc., Cerecor, Inc., Cyberonics, Inc., Janssen Pharmaceutica, Medtronic, Inc., Naurex, Inc., Nestle’ Health Science, Pfizer, Inc., Takeda Pharmaceuticals. Grant/Research Support: Allergan, Inc., Assurex, Inc., Avanir Pharmaceuticals, Cerecor, Inc., Genomind, Janssen Pharmaceutica , Naurex, Inc., Novartis Pharmaceuticals, Otsuka America, Nestle’ Health Science, Takeda Pharmaceuticals. Dr. McElroy is a consultant to or member of the scientific advisory boards of Allergen, Alkermes, Corcept, Ironshore, MedAvante, Naurex, NovoNordisk, Shire, Sunovian, and Teva. She is a principal or co-investigator on studies sponsored by the Agency for Healthcare Research & Quality (AHRQ), Azevan, Alkermes, AstraZeneca, Cephalon, Eli Lilly and Company, Marriott Foundation, National Institute of Mental Health, Orexigen Therapeutics, Inc., Shire, Sunovian,Takeda Pharmaceutical Company Ltd., and Transcept Pharmaceutical, Inc. She is also an inventor on United States Patent No. 6,323,236 B2, Use of Sulfamate Derivatives for Treating Impulse Control Disorders, and along with the patent’s assignee, The University of Cincinnati, Cincinnati, Ohio, has received payments from Johnson & Johnson, which has exclusive rights under the patent. Dr. Friedman receives royalties from Springer. Mr. Rabideau reports no competing interests. Dr. Nierenberg is a consultant for Abbott Laboratories, Alkermes, American Psychiatric Association, Appliance Computing Inc. (Mindsite), Basliea, Brain Cells, Inc., Brandeis University, Bristol Myers Squibb, Clintara, Corcept, Dey Pharmaceuticals, Dainippon Sumitomo (now Sunovion), Eli Lilly and Company, EpiQ, L.P./Mylan Inc., Forest, Genaissance, Genentech, GlaxoSmithKline, Healthcare Global Village, Hoffman LaRoche, Infomedic, Intra-Cellular Therapies, Lundbeck, Janssen Pharmaceutica, Jazz Pharmaceuticals, Medavante, Merck, Methylation Sciences, NeuroRx, Naurex, Novartis, PamLabs, Parexel, Pfizer, PGx Health, Otsuka, Ridge Diagnostics Shire, Schering-Plough, Somerset, Sunovion, Takeda Pharmaceuticals, Targacept, and Teva; consulted through the MGH Clinical Trials Network and Institute (CTNI) for Astra Zeneca, Brain Cells, Inc, Dianippon Sumitomo/Sepracor, Johnson and Johnson, Labopharm, Merck, Methylation Science, Novartis, PGx Health, Shire, Schering-Plough, Targacept and Takeda/Lundbeck Pharmaceuticals. He is a stakeholder in Appliance Computing, Inc. (MindSite), Brain Cells, Inc., and Medavante. He receives research support from American Foundation for Suicide Prevention, AHRQ, Brain and Behavior Research Foundation, Bristol-Myers Squibb, Cederroth, Cephalon, Cyberonics, Elan, Eli Lilly, Forest, GlaxoSmithKline, Intra-Cellular Therapies, Janssen Pharmaceutica, Lichtwer Pharma, Marriott Foundation, Mylan, NIMH, PamLabs, PCORI, Pfizer Pharmaceuticals, Shire, Stanley Foundation, Takeda, and Wyeth-Ayerst. Honoraria include Belvoir Publishing, The University of Texas Southwestern Dallas, Brandeis University, Bristol-Myers Squibb, Hillside Hospital, American Drug Utilization Review, American Society for Clinical Psychopharmacology, Baystate Medical Center, Columbia University, CRICO, Dartmouth Medical School, Health New England, Harold Grinspoon Charitable Foundation, IMEDEX, International Society for Bipolar Disorder, Israel Society for Biological Psychiatry, Johns Hopkins University, MJ Consulting, New York State, Medscape, MBL Publishing, MGH Psychiatry Academy, National Association of Continuing Education, Physicians Postgraduate Press, SUNY Buffalo, The University of Wisconsin, The University of Pisa, The University of Michigan, The University of Miami, The University of Wisconsin at Madison, APSARD, ISBD, SciMed, Slack Publishing and Wolters Klower Publishing, ASCP, NCDEU, Rush Medical College, Yale University School of Medicine, NNDC, Nova Southeastern University, NAMI, Institute of Medicine, CME Institute, ISCTM, World Congress on Brain Behavior and Emotion, Congress of the Hellenic Society for Basic and Clinical Pharmacology, and ADAA. He has copyright joint ownership with MGH for Structured Clinical Interview for MADRS and Clinical Positive Affect Scale.
Consent to publish
Consent to publish this work has been obtained from the participant (or legal parent or guardian for children) to report individual patient data.
Ethics, consent, and permissions
This study was approved by the Internal Review Board at the Coordinating Center for this study, or Massachusetts General Hospital (Protocol # 2010P001442), as well as the Internal Review Boards at each study site. All participants were consented to participate in this study.