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Article History

Accepted: 6 June 2024

First Online: 2 July 2024

Declarations

:

: This study was funded by Teva Branded Pharmaceutical Products R&D, Inc. The sponsor participated in the design and conduct of the study and in the collection, management, analysis, and interpretation of the data and funded the preparation of the manuscript. All authors, including those affiliated with the sponsor, fulfilled all authorship criteria and participated in the review and approval of the manuscript and in the decision to submit the manuscript for publication.

: J.M.K. has been a consultant for or received honoraria from Alkermes, Boehringer Ingelheim, Cerevel, Click Therapuetics, Eli Lilly, EnVivo Pharmaceuticals (Forum), Forest (Allergan), Genentech, HLS Therapuetics, Intra-Cellular Therapies, Janssen, Johnson & Johnson, Karuna Therapeutics, LB Pharmaceuticals, Lundbeck, Lyndra Therapeutics, Merck, Neurocrine Biosciences, Newron, Otsuka, Pierre Fabre, Reviva Pharmaceuticals, Roche, Saladax Biomedical, Sunovion, Takeda, and Teva Pharmaceuticals; has received grant support from Otsuka, Lundbeck, and Janssen; and is a shareholder of Cerevel, Health Rhythms, LB Pharmaceuticals, and Vanguard Research Group. R.E., E.H., O.T., A.E., H.K., K.R.F., G.L.D., and N.S. are employees or stockholders, or both, of Teva Pharmaceuticals. M.S. is an employee and stockholder of Teva UK. C.U.C. has been a consultant for or has received honoraria from AbbVie, Acadia Pharmaceuticals, Alkermes, Allergan, Angelini Pharma, Aristo Pharma, Biogen, Boehringer Ingelheim, Cardio Diagnostics, Cerevel Therapeutics, CNX Therapeutics, COMPASS Pathways, Darnitsa, Denovo Biopharma, Gedeon Richter, Hikma, Holmusk, Intra-Cellular Therapies, Janssen, Johnson & Johnson, Karuna Therapeutics, LB Pharmaceuticals, Laboratorios Farmacéuticos ROVI, Lundbeck, MedAvante-ProPhase, MedinCell, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine Biosciences, Neurelis, Newron Pharmaceuticals, Noven, Novo Nordisk, Otsuka, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Sunovion, Supernus Pharmaceuticals, Takeda, Teva Pharmaceuticals, and Viatris; has provided expert testimony for Janssen and Otsuka and served on data safety monitoring boards or advisory boards for COMPASS Pathways, Denovo Biopharma, Laboratorios Farmacéuticos ROVI, Lundbeck, Relmada, Reviva, Sage Therapeutics, Supernus Pharmaceuticals, Tolmar, and Teva Pharmaceuticals; has received grant support from Janssen and Takeda and received royalties from UpToDate; serves on the board of directors for the American Society of Clinical Psychopharmacology; and is a stock option shareholder of Cardio Diagnostics, Mindpax, LB Pharmaceuticals, PsiloSterics, and Quantic Group.

: The datasets used and/or analyzed for the study described in this manuscript are available upon reasonable request. Qualified researchers may request access to patient-level data and related study documents including the study protocol and the statistical analysis plan. Patient-level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit to make your request.

: The protocol and subsequent amendments were approved before the start of the study by independent ethics committees (IECs)/institutional review boards (IRBs) according to national or local regulations. IEC/IRB organizations and approval numbers for the study include the following: Western IRB (20180568), Western IRB and WCG (ICO1-18-072), Copernicus Group (20190551), and Republic of Bulgaria/Ethics Committee for Clinical Trials (KEMI/CT-0412). This study was conducted in full accordance with the International Council for Harmonisation Good Clinical Practice Consolidated Guideline (E6) and any applicable national and local laws and regulations.

: Patients provided informed consent or assent, as applicable, at screening, before any study-related procedures or assessments were performed.

: Not applicable.

: Not applicable.

: J.M.K., R.E., E.H., O.T., and N.S. conceived and designed the study. J.M.K., R.E., E.H., O.T., A.E., H.K., N.S., M.S., K.R.F., G.L.D., and C.U.C. acquired, analyzed, and interpreted the data. R.E., E.H., O.T., A.E., H.K., N.S., G.L.D., and C.U.C. verified the data. J.M.K., R.E., E.H., O.T., A.E., H.K., N.S., M.S., K.R.F., G.L.D., and C.U.C. accessed the data. J.M.K., R.E., E.H., O.T., A.E., H.K., N.S., M.S., K.R.F., G.L.D., and C.U.C. drafted the manuscript. J.M.K., R.E., E.H., O.T., A.E., H.K., N.S., M.S., K.R.F., G.L.D., and C.U.C. critically revised the manuscript for important intellectual content. N.S. did the statistical analysis. G.L.D. provided administrative, technical, or material support. J.M.K., R.E., E.H., O.T., A.E., H.K., N.S., M.S., K.R.F., G.L.D., and C.U.C. approved the final submitted version and agree to be accountable for the work.