DelBello, Melissa P.
Findling, Robert L.
Huss, Michael
Necking, Oscar
Petersen, Maria L.
Schmidt, Simon N.
Rosen, Monika
Funding for this research was provided by:
Takeda Pharmaceuticals U.S.A.
Lundbeck LLC
Article History
Received: 3 October 2023
Accepted: 7 August 2024
First Online: 6 September 2024
Declarations
:
: Study protocols and amendments were approved by the relevant independent ethics committee in accordance with local requirements. These studies were conducted in compliance with Good Clinical Practice and in accordance with the ethical principles described in the Declaration of Helsinki. The unblinded safety data from the lead-in studies and both extension studies were monitored by a data monitoring committee to ensure ethical principles.
: Written assent from the patients and written informed consent from the patients’ parents or legal representatives were obtained before the start of any study-related activities.
: M. DelBello has received research support from AbbVie, Acadia, Allergen, Alkeremes, Axsome, Janssen, Johnson & Johnson, Lundbeck, Otsuka, Pfizer, Sage, Shire, Sunovion, Supernus Pharmaceuticals, and Vanda, and has served/acted as a consultant and/or has received honoraria from Alkermes, Allergan, American Academy of Child & Adolescent Psychiatry, Assurex, CMEology, Janssen, Johnson & Johnson, Lundbeck, Merck, Myriad, Neuronetics, Otsuka, Pfizer, Sage, Sunovion, and Supernus Pharmaceuticals. R. Findling receives or has received research support, acted as a consultant and/or has received honoraria from AbbVie, Acadia, Adamas, Afecta, Ajna, Akili, Alkermes, Allergan, American Academy of Child & Adolescent Psychiatry, American Psychiatric Press, Arbor, Axsome, BioXcel, Idorsia, Intracellular Therapies, Iqvia, Lundbeck, Medavante Prophase, MJH Life Sciences, Neurim, NIH, Novartis, Otsuka, Oxford University Press, PaxMedica, PCORI, Pfizer, Physicians’ Postgraduate Press, Radius, Receptor Life Sciences, Sage, Signant Health, Sunovion, Supernus Pharmaceuticals, Syneos, Takeda, Tris, and Viatris. M. Huss has received research support, acted as a consultant, and/or has received honoraria from Eli Lilly, Engelhardt Pharmaceuticals, Janssen-Cilaq, Lundbeck, Medice, Novartis, Shire, Steiner Pharmaceuticals, and Takeda. M. Petersen, S. Schmidt, and M. Rosen are employees of H. Lundbeck A/S. O. Necking was an employee of H. Lundbeck A/S at the time of the study.