Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023 Jun 21;23(1):453.
doi: 10.1186/s12888-023-04928-0.

Delphi panel to obtain clinical consensus about using long-acting injectable antipsychotics to treat first-episode and early-phase schizophrenia: treatment goals and approaches to functional recovery

Celso Arango  1 , Andrea Fagiolini  2 , Philip Gorwood  3 , John M Kane  4   5   6 , Sergio Diaz-Mendoza  7 , Navdeep Sahota  8 , Christoph U Correll  9   10   11
Affiliations
Review

Delphi panel to obtain clinical consensus about using long-acting injectable antipsychotics to treat first-episode and early-phase schizophrenia: treatment goals and approaches to functional recovery

Celso Arango et al. BMC Psychiatry. .

Abstract

Background: Schizophrenia is mostly a chronic disorder whose symptoms include psychosis, negative symptoms and cognitive dysfunction. Poor adherence is common and related relapse can impair outcomes. Long-acting injectable antipsychotics (LAIs) may promote treatment adherence and decrease the likelihood of relapse and rehospitalization. Using LAIs in first-episode psychosis (FEP) and early-phase (EP) schizophrenia patients could benefit them, yet LAIs have traditionally been reserved for chronic patients.

Methods: A three-step modified Delphi panel process was used to obtain expert consensus on using LAIs with FEP and EP schizophrenia patients. A literature review and input from a steering committee of five experts in psychiatry were used to develop statements about patient population, adverse event management, and functional recovery. Recruited Delphi process psychiatrists rated the extent of their agreement with the statements over three rounds (Round 1: paper survey, 1:1 interview; Rounds 2-3: email survey). Analysis rules determined whether a statement progressed to the next round and the level of agreement deemed consensus. Measures of central tendency (mode, mean) and variability (interquartile range) were reported back to help panelists assess their previous responses in the context of those of the overall group.

Results: The Delphi panelists were 17 psychiatrists experienced in treating schizophrenia with LAIs, practicing in seven countries (France, Italy, US, Germany, Spain, Denmark, UK). Panelists were presented with 73 statements spanning three categories: patient population; medication dosage, management, and adverse events; and functional recovery domains and assessment. Fifty-five statements achieved ≥ 80% agreement (considered consensus). Statements with low agreement (40-79%) or very low agreement (< 39%) concerned initiating dosage in FEP and EP patients, and managing loss of efficacy and breakthrough episodes, reflecting current evidence gaps. The panel emphasized benefits of LAIs in FEP and EP patients, with consensus that LAIs can decrease the risk of relapse, rehospitalization, and functional dysfunction. The panel supported links between these benefits and multidimensional longer-term functional recovery beyond symptomatic remission.

Conclusions: Findings from this Delphi panel support the use of LAIs in FEP and EP schizophrenia patients regardless of disease severity, number of relapses, or social support status. Gaps in clinician knowledge make generating evidence on using LAIs in FEP and EP patients critical.

Keywords: Antipsychotics; Clinical consensus; Delphi process; Early-phase schizophrenia; First episode psychosis; Functional recovery; Long-acting injectable; Recommendations; Schizophrenia.

PubMed Disclaimer

Conflict of interest statement

While the authors do not have any competing interests as defined by BMC, the following are the author disclosures: Celso Arango has received support by 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. Dr. Arango has been a consultant to or has received honoraria or grants from Acadia, Angelini, Biogen, Boehringer, 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, Otsuka, Richter, Merk and Viatris.John M. Kane has been a consultant for or received honoraria from Alkermes, Allergan, Boehringer-Ingelheim, Cerevel, Dainippon Sumitomo, H. Lundbeck, HealthRhythms, HLS, Indivior, Intracellular Therapies, Janssen Pharmaceutical, Johnson & Johnson, LB Pharmaceuticals, Merck, Minerva, Neurocrine, Newron, Novartis, Otsuka, Roche, Saladax, Sunovion, and Teva. Dr. Kane has received grant support from Otsuka, Lundbeck, Sunovion and Janssen. Dr. Kane is a Shareholder in Vanguard Research Group, North Shore Therapeutics, Health Rhythms, MedinCell, and LB Pharmaceuticals, Inc.Andrea Fagiolini is /has been a consultant and/or a speaker and/or has received research grants from Angelini, Apsen, Boheringer Ingelheim, Daiichi Sankyo, Glaxo Smith Kline, Italfarmaco, Lundbeck, Janssen, Mylan, Otsuka, Pfizer, Recordati, Sanofi Aventis, Sunovion, Viatris, ViforChristoph 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 Pharma, 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 Pharma and Quantic.

Figures

Fig. 1
Fig. 1
Modified Delphi framework
Fig. 2
Fig. 2
Proportion of statements per category that achieved consensus, dissensus, or neither
See this image and copyright information in PMC

Update of

References

    1. Charlson FJ, Ferrari AJ, Santomauro DF, Diminic S, Stockings E, Scott JG, et al. Global epidemiology and burden of schizophrenia: findings from the global gurden of disease study 2016. Schizophr Bull. 2018 Oct;44(6):1195–203. - PMC - PubMed
    1. Kahn RS, Sommer IE, Murray RM, Meyer-Lindenberg A, Weinberger DR, Cannon TD, et al. Schizophrenia Nat Rev Dis Primers. 2015 Nov;12(1):1–23. - PubMed
    1. Giordano G, Tomassini L, Cuomo I, Amici E, Perrini F, Callovini G, et al. Aripiprazole long-acting injection during first episode schizophrenia—an exploratory analysis. Front Psychiatry. 2020 Jan;8:10:935. - PMC - PubMed
    1. Lippi G. Schizophrenia in a member of the family: Burden, expressed emotion and addressing the needs of the whole family. S Afr J Psychiatr 2016 Aug 31;22(1):922. - PMC - PubMed
    1. Kane JM, McEvoy JP, Correll CU, Llorca PM. Controversies surrounding the use of long-acting injectable antipsychotic medications for the treatment of patients with schizophrenia. CNS Drugs. 2021 Oct;35(11):1189–205. - PMC - PubMed

Publication types

Substances