Funding

Sponsorship for this analysis, the clinical trials upon which the analysis is based, and the publisher’s Rapid Service and Open Access fees were funded by BioXcel Therapeutics, Inc, New Haven, CT.

Medical Writing and Editorial Assistance

The authors acknowledge the assistance of Chris Caiazza for medical writing and Alix Bennett, PhD of BioXcel Therapeutics for editing in the development of this manuscript. Support for this assistance was provided by BioXcel Therapeutics, Inc, New Haven, CT.

Authorship

All authors contributed to the conceptualization of this analysis, preparation and review of the manuscript, and decision to submit for publication. The analysis was conducted by Leslie Citrome and Heather Robison. All authors read and approved the final manuscript.

Author Contributions

Leslie Citrome—concept and design, statistical analysis, drafting the manuscript. Lavanya Rajachandran—concept and design, drafting the manuscript. Robert Risinger—concept and design, drafting the manuscript. Heather Robison—concept and design, statistical analysis, drafting the manuscript.

Prior Presentation

This analysis was previously presented at the Academy of Managed Care Pharmacists Nexus conference, October 20, 2021, Denver, CO, and abstract published in Citrome L, et al. Journal of Managed Care Specialty Pharmacy. 2021; 27(10-a): S60-61. Some of the data upon which this analysis is based have been published in the Journal of the American Medical Association, 2022; 327(8);727–736, are in press in the Journal of Clinical Psychiatry and have been have been presented previously at the American Psychiatric Association, May 3, 2021, Virtual; Society for Academic Emergency Medicine, May 11, 2022, New Orleans, LA; International Society of Bipolar Disorders, May 15, 2021, Virtual; International Society of Bipolar Disorders, June 10, 2022, Virtual; American College of Emergency Physicians, October 25, 2021, Boston, MA; Psych Congress, October 30, 2021, San Antonio, TX; Neuroscience Education Institute, November 5, 2021, Colorado Springs, CO; American Society of Health Systems Pharmacists, December 5, 2021, Virtual; and American Academy of Emergency Psychiatry, December 9, 2021, Las Vegas, NV.

Disclosures

Leslie Citrome, MD, MPH, reported serving as chair of the drug monitoring committee for the clinical trials upon which this analysis is based, and as consultant to AbbVie/Allergan, Acadia, Adamas, Alkermes, Angelini, Astellas, Avanir, Axsome, BioXcel, Boehringer Ingelheim, Cadent Therapeutics, Eisai, Enteris BioPharma, HLS Therapeutics, Impel, Intra-Cellular Therapies, Janssen, Karuna, Lundbeck, Lyndra, Medavante-ProPhase, Merck, Neurocrine, Novartis, Noven, Otsuka, Ovid, Relmada, Reviva, Sage, Sunovion, Supernus, Teva, University of Arizona, and one-off ad hoc consulting for individuals/entities conducting marketing, commercial, or scientific scoping research; speaker for AbbVie/Allergan, Acadia, Alkermes, Angelini, Eisai, Intra-Cellular Therapies, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Sage, Sunovion, Takeda, Teva, and CME activities organized by medical education companies such as Medscape, NACCME, NEI, Vindico, and Universities and Professional Organizations/Societies; stock ownership (small number of shares of common stock) in Bristol-Myers Squibb, Eli Lilly, J & J, Merck, Pfizer purchased > 10 years ago, stock options: Reviva; and royalties from Wiley (Editor-in-Chief, International Journal of Clinical Practice, through end 2019), UpToDate (reviewer), Springer Healthcare (book), Elsevier (Topic Editor, Psychiatry, Clinical Therapeutics). Robert Risinger, Lavanya Rajachandran, and Heather Robison are employees of BioXcel Therapeutics.

Compliance with Ethics Guidelines

The clinical trials upon which this analysis was based were conducted in accordance with Good Clinical Practices and the Declaration of Helsinki and were approved by the institutional review board or ethics committee at each participating site. All patients provided written informed consent before any study procedures were undertaken.

Data Availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.