Pape, Julius C. http://orcid.org/0000-0001-9631-7093
Carrillo-Roa, Tania
Rothbaum, Barbara O.
Nemeroff, Charles B.
Czamara, Darina
Zannas, Anthony S.
Iosifescu, Dan
Mathew, Sanjay J.
Neylan, Thomas C.
Mayberg, Helen S.
Dunlop, Boadie W.
Binder, Elisabeth B.
Funding for this research was provided by:
National Institute of Mental Health (U19 MH069056, K23 MH086690)
National Institute of Mental Health (U19 MH069056)
GlaxoSmithKline (Study medication and Placebo, lab testing, funds for subject recruitment)
Neurocrine Biosciences (pharmacokinetic analyses)
Article History
Received: 23 July 2018
Accepted: 17 October 2018
First Online: 3 November 2018
Ethics approval and consent to participate
: The study is being conducted in accord with the latest version of the Declaration of Helsinki. Each site’s Institutional Review Board (IRB) approved the study design, procedures, and recruitment strategies, with Emory University serving as the lead site (Emory University IRB, IRB number 00022717; Mount Sinai School of Medicine IRB, IRB number 04-0900 0001 03; Baylor College of Medicine IRB, IRB number H-30433 and the Michael E DeBakey Veterans Affairs Medical Center Research and Development Program, ID number 12G19, HBP; University of California San Francisco IRB, and the San Francisco Veterans Affairs Research and Development Committee, IRB number 12-09929). The study is registered atExternalRef removed: NCT01018992. All participants provided written informed consent before the study.
: Not applicable
: Dr. Mayberg reports grants from NIMH, grants, and other from GSK, during the conduct of the study; personal fees from Abbott Labs (previously St Jude Medical Inc), outside the submitted work.Dr. Dunlop reports grants from the National Institute of Mental Health during the conduct of the study; grants from Takeda, grants from Janssen, grants from Acadia, grants from Axsome, outside the submitted work.Dr. Mathew has served as a consultant to Allergan, Alkermes, and Fortress Biotech. He has received research support from NeuroRx.Dr. Iosifescu reports grants from the National Institute of Mental Health, during the conduct of the study; personal fees from Axsome, personal fees from Alkermes, grants from Brainsway, grants from LiteCure, personal fees from Lundbeck, grants from Neosync, personal fees from Otsuka, personal fees from Sunovion, outside the submitted work.Dr. Nemeroff has received research support from the National Institutes of Health (NIH) and Stanley Medical Research Institute. For the last 3 years, he was a consultant for Xhale, Takeda, Taisho Pharmaceutical Inc., Prismic Pharmaceuticals, Bracket (Clintara), Fortress Biotech, Sunovion Pharmaceuticals Inc., Sumitomo Dainippon Pharma, Janssen Research & Development LLC, Magstim, Inc., Navitor Pharmaceuticals, Inc., TC MSO, Inc., Intra-Cellular Therapies, Inc. He is a Stockholder of Xhale, Celgene, Seattle Genetics, Abbvie, OPKO Health, Antares, BI Gen Holdings, Inc., and Corcept Therapeutics Pharmaceuticals Company. Dr. Nemeroff is a member of the scientific advisory boards of the American Foundation for Suicide Prevention (AFSP), Brain and Behavior Research Foundation (BBRF) (formerly named National Alliance for Research on Schizophrenia and Depression [NARSAD]), Xhale, Anxiety Disorder Association of America (ADAA), Skyland Trail, Bracket (Clintara), Laureate Institute for Brain Research, Inc. and on the board of directors of AFSP, Gratitude America and ADAA. Dr. Nemeroff has income sources or equity of 10.000 USD or more from American Psychiatric Publishing, Xhale, Bracket (Clintara), CME Outfitters, Takeda, Intra-Cellular Therapies, Inc., and Magstim. Dr. Nemeroff holds the following patents: Method and devices for transdermal delivery of lithium (US 6,375,990B1) and Method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitter by ex vivo assay (US 7,148,027B2).Dr. Binder, Dr. Rothbaum, Dr. Neylan, Dr. Pape, Dr. Carrillo-Roa, Dr. Czamara and Dr. Zannas have nothing to disclose.
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