Weiss, Catherine http://orcid.org/0000-0001-6712-4620
Meehan, Stine R.
Brown, T. Michelle
Gupta, Catherine
Mørup, Michael F.
Thase, Michael E.
McIntyre, Roger S.
Ismail, Zahinoor
Funding for this research was provided by:
H. Lundbeck A/S
Otsuka Pharmaceutical Development and Commercialization Inc.
Article History
Received: 23 April 2021
Accepted: 25 September 2021
First Online: 11 December 2021
Declarations
:
: The three clinical studies included in this analysis were conducted in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline and local regulatory requirements. The study protocols were approved by the following institutional review boards (IRBs): Schulman Associates IRB (Cincinnati, OH) or WIRB–Copernicus Group (Princeton, NJ). All patients provided written informed consent prior to the start of the study in which they were enrolled, after the nature of the intervention and possible side effects had been fully explained.
: Not applicable.
: CW was a full-time employee of Otsuka Pharmaceutical Development & Commercialization Inc. at the time that this work was conducted. SRM and MFM are full-time employees of H. Lundbeck A/S. TMB and CG declare no conflicts of interest. MET has served as an advisor/consultant for Acadia Inc, Akili Inc, Alkermes Plc, Allergan Inc, Axsome, BioHaven Inc, Clexio Pharma, Gerson Lehrman Group Inc, H. Lundbeck A/S, Jazz Pharmaceuticals, Johnson & Johnson, Merck & Company Inc, Otsuka Pharmaceutical Company Ltd, Pfizer Inc, Sage Pharmaceuticals, Seelos Pharmaceuticals, Sunovion Pharmaceuticals Inc, Takeda Pharmaceutical Company Ltd; he has received grant support from 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; and royalties from American Psychiatric Foundation, Guilford Publications, Herald House, Kluwer-Wolters, WW Norton & Company Inc; and his spouse is employed by Peloton Advantage, which does business with most major pharmaceutical companies. RSM has received research grant support from CIHR/GACD/Chinese National Natural Research Foundation; and speaker/consultation fees from Lundbeck, Janssen, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, and AbbVie. He is a CEO of Braxia Scientific Corp. ZI has received grant support from CIHR, NIH, Brain Canada, Weston Foundation, and Janssen, and has served as a consultant for Janssen, Lundbeck and Otsuka. Additionally, his institution has received funds on his behalf from Acadia, Biogen, Roche, and Sunovion.