Abstract
Summary
Antipsychotics are a type of medicine used to treat the symptoms of schizophrenia. These medicines come in various forms, including long-acting injectables (LAIs), which are taken every few weeks or months.
There may be differences amongst doctors in how they approach treatment of people who are in the early phase of schizophrenia and experiencing symptoms for the first time. For instance, there may be differences in how the doctors prescribe antipsychotics, or in how they judge that their patient has recovered enough to function in their daily lives (also known as functional recovery).
This summary is based on two articles that reported results from a special process called the Delphi technique. This aimed to gain agreement from a group of experts on how LAI antipsychotics should be used for people living with early phase schizophrenia. Another aim was to gain agreement on what functional recovery looks like and how it can be assessed.
Based on expert agreement obtained through the Delphi technique, people with early schizophrenia could benefit from LAI antipsychotics. It was also agreed that LAIs may help people living with early phase schizophrenia reach functional recovery. Functional recovery can be represented by key aspects including depression, aggressive behavior, and social interactions. In the future, it would be useful to develop a survey or questionnaire that could assess all these key aspects.
Footnotes
Acknowledgements
Writing and editorial support for this summary was provided by Lyndal Staples, BSc, assisted by her colleagues all of the Prime Group of Companies (Knutsford, UK), and funded by Otsuka Pharmaceutical Development & Commercialization Inc. and H. Lundbeck A/S.
Ethics approval and consent to participate
Ethics approval and consent to participate were sought from Pearl Pathways (reference: #23-OHTH-106, 30/1/2023), a central institutional review board who reviewed and approved all study material including the protocol. Given the fact that no individual patient data were collected in the course of this study and physician participation was voluntary, this study was determined to be Exempt according to the FDA 21 CFR 56.104 and 45CFR46.104(d)(2). The study was conducted in accordance with the relevant guidelines and regulations for research involving human subjects. Information on the study purpose, format, and outputs were provided to the panelists through a market research agreement document. Informed consent was obtained from all panelists before their participation in this Delphi panel.
Author contributions
All authors contributed to study conceptualization. E. Arcà, A. Barlassina, C. Arango, A. Fagiolini, P. Gorwood, J.M. Kane, and C.U. Correll contributed to development of the methodology. E.A. and A.B. contributed to the formal analysis. All authors were involved in review and editing of manuscript drafts.
Funding
This work was sponsored by the Lundbeck Otsuka Alliance. The sponsors were involved in the design of the study, the collection, analysis and interpretation of data, the writing and reviewing of this article, and the decision to submit the article for publication.
Conflict of interest statement
Andrea Fagiolini is/has been a consultant and/or a speaker and/or has received research grants from Angelini, Aspen, Boehringer Ingelheim, Daiichi Sankyo, GlaxoSmithKline, Italfarmaco, Lundbeck, Janssen, Mylan, Otsuka, Pfizer, Recordati, Sanofi Aventis, Sunovion, Viatris, and Vifor. Murat Yildirim is a full-time employee of H. Lundbeck A/S. Celso Arango has received support from the Spanish Ministry of Science and Innovation, Instituto de Salud Carlos III (ISCIII), co-financed by the European Union, ERDF Funds from the European Commission, “A way of making Europe”, financed by the European Union - NextGenerationEU (PMP21/00051), PI19/01024, CIBERSAM, Madrid Regional Government (B2017/BMD-3740 AGES-CM-2), European Union Structural Funds, European Union Seventh Framework Program, European Union H2020 Program under the Innovative Medicines Initiative 2 Joint Undertaking: Project PRISM-2 (Grant agreement No. 101034377), Project AIMS-2-TRIALS (Grant agreement No. 777394), Horizon Europe, the National Institute of Mental Health of the National Institutes of Health under Award Number 1U01MH124639-01 (Project ProNET) and Award Number 5P50MH115846- 03 (project FEP-CAUSAL), Fundación Familia Alonso, and Fundación Alicia Koplowitz. He has been a consultant to or has received honoraria or grants from Acadia, Angelini, Biogen, Boehringer Ingelheim, Gedeon Richter, Janssen Cilag, Lundbeck, Medscape, Menarini, Minerva, Otsuka, Pfizer, Roche, Sage, Servier, Shire, Schering Plough, Sumitomo Dainippon Pharma, Sunovion, and Takeda. Philip Gorwood received during the last 5 years fees for presentations at congresses or participation in scientific boards from Angelini, EISI, Janssen, Lundbeck, MindMed, Newron, Otsuka, Richter, Merck, and Viatris. Christoph U. Correll has been a consultant and/or advisor to or has received honoraria from AbbVie, Acadia, Alkermes, Allergan, Angelini, Aristo, Boehringer Ingelheim, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnitsa, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Janssen/J&J, Karuna, LB Pharmaceuticals, Lundbeck, MedAvante-ProPhase, Medincell, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Newron, Noven, Otsuka, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Seqirus, SK Life Science, Sunovion, Sun Pharma, Supernus, Takeda, Teva, and Viatris. He provided expert testimony for Janssen and Otsuka. He served on a Data Safety Monitoring Board for Compass, Lundbeck, Relmada, Reviva, Rovi, Supernus, and Teva. He has received grant support from Janssen and Takeda. He received royalties from UpToDate and is also a stock option holder of Cardio Diagnostics, Mindpax, LB Pharmaceuticals, and Quantic. Adele Barlassina and Emanuele Arcà are employees of OPEN Health. John M. Kane has been a consultant and/or advisor to or has received honoraria from AbbVie, Alkermes, Boehringer Ingelheim, Bristol Myers Squibb, Cerevel, Click Therapeutics, Dainippon Sumitomo, H. Lundbeck, Intra-Cellular Therapies, Janssen/J&J, Karuna, LB Pharmaceuticals, Merck, Newron, NWPharmaTech, Otsuka, Reviva, Roche, Saladax, Sunovion, and Teva. He has received grant support from Otsuka, H. Lundbeck, Sunovion, and Janssen. He is a shareholder in Vanguard Research Group, North Shore Therapeutics, Health Rhythms, MedinCell, and LB Pharmaceuticals, Inc.
Availability of data and material
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.