Wozniak, Janet
DiSalvo, Maura
Farrell, Abigail
Vaudreuil, Carrie
Uchida, Mai
Ceranoglu, T. Atilla
Joshi, Gagan
Cook, Emmaline
Faraone, Stephen V.
Biederman, Joseph
Funding for this research was provided by:
Lisa and Philip Astley-Sparke
Article History
Received: 9 June 2021
Accepted: 7 April 2022
First Online: 3 May 2022
Declarations
:
: All study procedures were reviewed and approved by the committee for human subjects at our institution. The Mass General Brigham Institutional Review Boards (IRBs) is the committee/institutional review board that approved this study. Written informed consent was obtained from all the participants and their parents/guardians of minors. Consent was obtained by a study clinician who explained the study in detail, including risks and benefits of participation, and participant and parent were encouraged to ask questions. Participation in the study was optional and participants could withdraw consent at any time. This is a clinical trial with human participants. All research staff successfully completed the Good Clinical Practice (GCP) course based on the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ICH-GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the United States (US). This study was in full compliance with the standards and guidelines set forth by the ICH-GCP and consistent with the principles of the Declaration of Helsinki.
: Not applicable.
: Dr. Janet Wozniak receives research support from PCORI and Demarest Lloyd, Jr. Foundation. In the past, Dr. Wozniak has received research support, consultation fees or speaker’s fees from Eli Lilly, Janssen, Johnson and Johnson, McNeil, Merck/Schering-Plough, the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH), Pfizer, and Shire. She is the author of the book, “Is Your Child Bipolar” published May 2008, Bantam Books. Her spouse receives royalties from UpToDate; consultation fees from Emalex, Noctrix, Disc Medicine, Avadel, HALEO, OrbiMed, and CVS; and research support from Merck, NeuroMetrix, American Regent, NIH, NIMH, the RLS Foundation, and the Ellison Baszucki Donor Fund. In the past, he has received honoraria, royalties, research support, consultation fees or speaker’s fees from: Otsuka, Cambridge University Press, Advance Medical, Arbor Pharmaceuticals, Axon Labs, Boehringer-Ingelheim, Cantor Colburn, Covance, Cephalon, Eli Lilly, FlexPharma, GlaxoSmithKline, Impax, Jazz Pharmaceuticals, King, Luitpold, Novartis, Neurogen, Novadel Pharma, Pfizer, Sanofi-Aventis, Sepracor, Sunovion, Takeda, UCB (Schwarz) Pharma, Wyeth, Xenoport, Zeo.Dr. Mai Uchida receives research support from the NIMH under Award Number 1K23MH122667-01.Dr. T. Atilla Ceranoglu has received research support from PAMLab, Roche Inc., Pfizer, Sunovion Pharmaceuticals Inc., Department of Defense, H. Lundbeck A/S, Magceutics, Massachusetts Department of Mental Health, National Institutes of Health, and Massachusetts General Hospital. He has acted as a consultant for Guidepoint Global LLC and L.E.K. Consulting. Dr. Ceranoglu has received honoraria and travel support from Prima Barn och Vuxenpsykiatri.Dr. Gagan Joshi is supported by the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH) under Award Number K23MH100450. In the last year he has received research support from the Demarest Lloyd, Jr. Foundation as a primary investigator (PI) for investigator-initiated studies. Additionally, he receives research support F. Hoffmann-La Roche Ltd. as a site PI for multi-site trials. In the past three years, he has received research support from Pfizer and the Simons Center for the Social Brain. In addition, he has received honorarium from the Governor's Council for Medical Research and Treatment of Autism in New Jersey and from NIMH for grant review activities. Finally, he received speaker’s honorariums from the American Academy of Child and Adolescent Psychiatry, The Israeli Society of ADHD, the Canadian Academy of Child and Adolescent Psychiatry, and the University of Jülich.In the past year, Dr. Stephen V. Faraone received income, potential income, travel expenses continuing education support and/or research support from, Akili Interactive Labs, Arbor, Genomind, Ironshore, KemPharm/Corium, Ondosis, Otsuka, Rhodes, Shire/Takeda, Sunovion, Supernus, Tris, and Vallon. With his institution, he has US patent US20130217707 A1 for the use of sodium-hydrogen exchange inhibitors in the treatment of ADHD. In previous years, he received support from: Alcobra, Aveksham, CogCubed, Eli Lilly, Enzymotec, Impact, Janssen, KemPharm, Lundbeck/Takeda, McNeil, Neurolifesciences, Neurovance, Novartis, Pfizer, and Vaya. He also receives royalties from books published by Guilford Press: <i>Straight Talk about Your Child’s Mental Health</i>; Oxford University Press: <i>Schizophrenia: The Facts;</i> and Elsevier: <i>ADHD</i><i>: </i><i>Non-Pharmacologic Interventions.</i> He is also Program Director of ExternalRef removed. Dr. Faraone is supported by the European Union’s Horizon 2020 research and innovation programme under grant agreement No 667302 and NIMH grants U01 MH109536-01, 1R01MH116037-01A1 and 1R01AG06495502.Dr. Joseph Biederman is currently receiving research support from the following sources: AACAP, Feinstein Institute for Medical Research, Genentech, Headspace Inc., NIDA, Pfizer Pharmaceuticals, Roche TCRC Inc., Sunovion Pharmaceuticals Inc., Takeda/Shire Pharmaceuticals Inc., Tris, and NIH. Dr. Biederman and his program have received royalties from a copyrighted rating scale used for ADHD diagnoses, paid by Biomarin, Bracket Global, Cogstate, Ingenix, Medavent Prophase, Shire, Sunovion, and Theravance; these royalties were paid to the Department of Psychiatry at MGH. Through Partners Healthcare Innovation, Dr. Biederman has a partnership with MEMOTEXT to commercialize a digital health intervention to improve adherence in ADHD. Through MGH corporate licensing, Dr. Biederman has a US Patent (#14/027,676) for a non-stimulant treatment for ADHD, a US Patent (#10,245,271 B2) on a treatment of impaired cognitive flexibility, and a patent pending (#61/233,686) on a method to prevent stimulant abuse. In 2020: Dr. Biederman received an honorarium for a scientific presentation from Tris, and research support from the Food & Drug Administration. He receives honoraria from the Medlearning Inc and MGH Psychiatry Academy for tuition-funded CME courses. In 2019, Dr. Biederman was a consultant for Akili, Avekshan, Jazz Pharma, and Shire/Takeda. He received research support from Lundbeck AS and Neurocentria Inc. Through MGH CTNI, he participated in a scientific advisory board for Supernus. He received honoraria from the MGH Psychiatry Academy for tuition-funded CME courses. In 2018, Dr. Biederman was a consultant for Akili and Shire. He received honoraria from the MGH Psychiatry Academy for tuition-funded CME courses. In 2017, Dr. Biederman received research support from the Department of Defense and PamLab. He was a consultant for Aevi Genomics, Akili, Guidepoint, Ironshore, Medgenics, and Piper Jaffray. He was on the scientific advisory board for Alcobra and Shire. He received honoraria from the MGH Psychiatry Academy for tuition-funded CME courses. In previous years, Dr. Biederman received research support, consultation fees, or speaker’s fees for/from the following additional sources: AACAP, Abbott, Akili, Alcobra, Alza, APSARD, Arbor Pharmaceuticals, AstraZeneca, Avekshan, Boston University, Bristol Myers Squibb, Cambridge University Press, Celltech, Cephalon, The Children’s Hospital of Southwest Florida/Lee Memorial Health System, Cipher Pharmaceuticals Inc., Eli Lilly and Co., Esai, ElMindA, Forest Research Institute, Fundacion Areces (Spain), Forest, Fundación Dr.Manuel Camelo A.C., Glaxo, Gliatech, Hastings Center, Ironshore, Janssen, Juste Pharmaceutical Spain, Magceutics, McNeil, Medgenics, Medice Pharmaceuticals (Germany), Merck, MGH Psychiatry Academy, MMC Pediatric, NARSAD, NIDA, New River, NICHD, NIMH, Novartis, Noven, Neurosearch, Organon, Otsuka, Pfizer, Pharmacia, Phase V Communications, Physicians Academy, The Prechter Foundation, Quantia Communications, Reed Exhibitions, Shionogi Pharma Inc, Shire, the Spanish Child Psychiatry Association, SPRITES, The Stanley Foundation, UCB Pharma Inc., Vaya Pharma/Enzymotec, Veritas, and Wyeth.Ms. Maura DiSalvo, Ms. Abigail Farrell, Dr. Carrie Vaudreuil, and Ms. Emmaline Cook have nothing to disclose.