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Therapeutic Advances in Psychopharmacology logoLink to Therapeutic Advances in Psychopharmacology
. 2024 Nov 12;14:20451253241286319. doi: 10.1177/20451253241286319

Plain Language Summary of Publication: A comparison of once-monthly and once-every-2-months injectable formulations of aripiprazole in people with schizophrenia

Leslie Citrome 1, Pedro Such 2, Murat Yildirim 2, Jessica Madera-McDonough 3, Clodagh Beckham 4, Na Jin 3, Suzanne Watkin 3, Zhen Zhang 3, Frank Larsen 2, Matthew Harlin 3,
PMCID: PMC11555728  PMID: 39534012

Abstract

The purpose of this summary is to explain key findings from a study that included people with schizophrenia, as described in two separate articles (see the ‘Further Information’ section for more details).

The study compared a new formulation of aripiprazole, given as an injection once every 2 months, with a once‑monthly injection of aripiprazole.

Keywords: Antipsychotic, Aripiprazole, Schizophrenia, Long-acting injectable


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Acknowledgments

Writing and editorial support for this summary was provided by Lyndal Staples, assisted by her colleagues at Cambridge – a Prime Global Agency (Knutsford, UK), and funded by Otsuka Pharmaceutical Development & Commercialization Inc. and H. Lundbeck A/S.

Declarations

Ethics approval and consent to participate: The study was conducted in accordance with the International Council for Harmonization Good Clinical Practice guidelines and local regulatory requirements. The study protocol was approved by the governing institutional review board (IRB) or independent ethics committee for each investigational site. Participating sites were within the United States and utilized the central IRB Advarra. Advarra IRB approved each site by issuing a dated approval letter. Each site was approved by Advarra IRB prior to the site initiation visit and prior to screening potential participants. All patients provided written informed consent prior to the start of the study.

Consent for publication: Not applicable.

Author contributions: Leslie Citrome: Formal analysis; Writing – original draft; Writing – review & editing.

Pedro Such: Formal analysis; Writing – original draft; Writing – review & editing.

Murat Yildirim: Formal analysis; Writing – original draft; Writing – review & editing.

Jessica Madera-McDonough: Formal analysis; Writing – original draft; Writing – review & editing.

Clodagh Beckham: Formal analysis; Writing – original draft; Writing – review & editing.

Na Jin: Formal analysis; Writing – original draft; Writing – review & editing.

Suzanne Watkin: Formal analysis; Writing – original draft; Writing – review & editing.

Zhen Zhang: Formal analysis; Writing – original draft; Writing – review & editing.

Frank Larsen: Conceptualization; Formal analysis; Methodology; Writing – original draft; Writing – review & editing.

Matthew Harlin: Conceptualization; Formal analysis; Methodology; Writing – original draft; Writing – review & editing.

Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was sponsored by Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Denmark). 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.

Competing interests: Leslie Citrome has served as consultant to AbbVie/Allergan, Acadia, Adamas, Alkermes, Angelini, Astellas, Avanir, Axsome, BioXcel, Boehringer Ingelheim, Cadent Therapeutics, Cerevel, Clinilabs, COMPASS, Eisai, Enteris BioPharma, HLS Therapeutics, Idorsia, Impel, INmune Bio, Intra-Cellular Therapies, Janssen, Karuna, Lundbeck, Lyndra, Marvin, Medavante-ProPhase, Merck, Mitsubishi-Tanabe Pharma, Neurelis, Neurocrine, Novartis, Noven, Otsuka, Ovid, Praxis, Recordati, Relmada, Reviva, Sage, Sunovion, Supernus, Teva, University of Arizona, and Vanda, and has done one-off ad hoc consulting for individuals/entities conducting marketing, commercial, or scientific scoping research. He has served as speaker for AbbVie/Allergan, Acadia, Alkermes, Angelini, Axsome, BioXcel, Eisai, Idorsia, Intra-Cellular Therapies, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Recordati, Sage, Sunovion, Takeda, and Teva, and contributed to CME activities organized by medical education companies such as Medscape, NACCME, NEI, Vindico, and universities and professional organizations/societies. He holds a small number of shares of common stock with Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, and Pfizer (purchased >10 years ago). He currently has options for acquiring stocks with Reviva. He has received royalties or income from publishing from Taylor & Francis (Editor-in-Chief, Current Medical Research and Opinion, 2022–date), Wiley (Editor-in-Chief, International Journal of Clinical Practice, through end 2019), UpToDate (reviewer), Springer Healthcare (book), and Elsevier (Topic Editor, Psychiatry, Clinical Therapeutics). Matthew Harlin, Na Jin, Suzanne Watkin, and Zhen Zhang are full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc. At the time of the study, Jessica Madera-McDonough was a full-time employee of Otsuka Pharmaceutical Development & Commercialization Inc. Clodagh Beckham is a full-time employee of Otsuka Pharmaceutical Europe Ltd. Frank Larsen, Pedro Such, and Murat Yildirim are full-time employees of H. Lundbeck A/S.

Availability of data and materials: To submit inquiries related to Otsuka clinical research, or to request access to individual participant data (IPD) associated with any Otsuka clinical trial, please visit https://clinical-trials.otsuka.com/. For all approved IPD access requests, Otsuka will share anonymized IPD on a remotely accessible data sharing platform.


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