Initiation of aripiprazole once-monthly using a two-injection start in adult patients diagnosed with schizophrenia: real-world views and experiences of Italian healthcare professionals

MURAT YILDIRIM1, CLODAGH BECKHAM2*, SOFIA PAPPA3, KAROLINA LEOPOLD4,5, WILLIAM J. COTTAM6*, JOE HICKEY6, OLIVIA ROGERSON6*, ANDREA FAGIOLINI7

1H. Lundbeck A/S, Valby, Denmark; 2Otsuka Pharmaceutical Europe, Berkshire, UK; 3Division of Psychiatry, Department of Brain Sciences, Imperial College London, UK; 4Vivantes Hospital am Urban and Vivantes Hospital im Friedrichshain, Charite, Universitätsmedizin, Berlin, Germany; 5Carl Gustav Carus University Hospital, Technische Universität Dresden, Germany; 6Real-World Evidence, OPEN Health, London, UK; 7Department of Mulecolar and Developmetal Medicine, Università di Siena, Italy.

*Affiliation at the time the research was conducted.

Summary. Aim. In Italy, aripiprazole once-monthly 400 mg (AOM 400) can be initiated using a two-injection start (TIS) in adult patients diagnosed with schizophrenia who are stabilised with oral aripiprazole. With this approach, treatment initiation is completed in a single day, without the need for 14 days of concurrent oral aripiprazole supplementation. This study examined how healthcare professionals (HCPs) view and use the AOM 400-TIS in real-world clinical practice in Italy, a country where uptake of the AOM 400-TIS has been relatively high. Methods. Responses were analysed for Italian physicians and nurses who participated in a pan-European, non-interventional, cross-sectional online survey that explored perspectives and attitudes towards prescribing and/or administering AOM 400-TIS in patients diagnosed with schizophrenia. Responses were collected across two waves and were analysed descriptively. Results. Responses were available for 108 Italian HCPs, representing 47.2% of all survey participants. Common reasons for using the AOM 400-TIS were poor treatment adherence (81.5%), patient preference (50.0%), and disease relapse (42.6%), while common barriers to its use were patient reluctance to receive two injections (36.1%), concerns about tolerability (24.1%), and concerns about safety (23.1%). Most HCPs agreed or strongly agreed that the AOM 400-TIS resulted in satisfactory patient outcomes (85.2%), was easy to administer (82.4%), and had a safety/tolerability profile similar to the traditional one-injection start (69.4%). Discussion. The results confirm the favourable clinical opinions, perspectives, and experiences of Italian HCPs who prescribe and/or administer the AOM 400-TIS in clinical practice.

Key words. Aripiprazole once-monthly, clinical practice, long-acting injectable, real-world perspectives, survey, two-injection start, 1-day initiation regimen.

Inizio di aripiprazolo una volta al mese tramite due iniezioni in pazienti adulti con schizofrenia: prospettive ed esperienze cliniche di professionisti sanitari italiani.

Riassunto. Obiettivo. In Italia, la terapia con aripiprazolo 400 mg una volta al mese (AOM 400) può essere iniziata con la somministrazione di due iniezioni (TIS) in pazienti adulti diagnosticati con schizofrenia e stabilizzati con aripiprazolo orale. Con questo approccio, il trattamento raggiunge livelli ematici efficaci in un solo giorno, senza necessitare di 14 giorni di integrazione concomitante con aripiprazolo orale. Questo studio ha esaminato come i professionisti sanitari (HCP) percepiscono e utilizzano l’AOM 400-TIS nella loro pratica clinica in Italia, un Paese dove l’adozione dell’AOM 400-TIS è stata relativamente elevata. Metodi. Le risposte analizzate sono state fornite da medici e infermieri italiani che hanno partecipato a un’indagine online paneuropea, non interventistica e trasversale che ha esplorato prospettive e attitudini nei confronti della prescrizione e/o somministrazione di AOM 400-TIS in pazienti diagnosticati con schizofrenia. Le risposte sono state raccolte in due tempi e analizzate in maniera descrittiva. Risultati. Sono state raccolte e analizzate le risposte di 108 operatori sanitari italiani, che rappresentano il 47,2% di tutti i partecipanti al sondaggio. Frequenti motivazioni per l’uso dell’AOM 400-TIS sono state: scarsa aderenza al trattamento (81,5%), preferenza del paziente (50,0%) e ricaduta della malattia (42,6%). Ostacoli comuni al suo utilizzo sono invece risultati: riluttanza del paziente a ricevere due iniezioni (36,1%) e preoccupazioni riguardo tollerabilità (24,1%), e preoccupazioni riguardo sicurezza (23,1%). La maggior parte degli operatori sanitari concorda, o concorda fortemente, che l’AOM 400-TIS sia facile da somministrare (82,4%), abbia un profilo di sicurezza/tollerabilità simile a quello tradizionale di avvio con una sola iniezione (69,4%) e porti a risultati soddisfacenti per i pazienti (85,2%). Discussione. I risultati confermano le opinioni cliniche positive, le prospettive e le esperienze degli operatori sanitari italiani che prescrivono e/o somministrano l’AOM 400-TIS nella pratica clinica.

Parole chiave. Aripiprazolo una volta al mese, avvio con due iniezioni, iniettabile a lunga durata, pratica clinica, prospettive cliniche, sondaggio, regime di avvio di 1 giorno.

Introduction

Aripiprazole monohydrate long-acting injectables (LAIs) include a once-monthly formulation (aripiprazole once-monthly 400 mg [AOM 400]), which is approved in Europe for the maintenance treatment of adult patients diagnosed with schizophrenia who are stabilised with oral aripiprazole1. More recently, a once-every-2-months formulation has been approved (aripiprazole 2-month ready-to-use 960 mg [Ari 2MRTU 960])1, which has a similar pharmacokinetic, safety/tolerability, and efficacy profile to AOM 400 in people diagnosed with schizophrenia2-4.

AOM 400 has been available and reimbursed in Italy since July 2014. At the time of its approval, treatment initiation comprised a single injection of AOM 400 plus 14 consecutive days of oral aripiprazole. In October 2020, a simplified initiation regimen for AOM 400 was approved by the European Medicines Agency. This regimen, variously referred to as the two-injection start (TIS) or the 1-day initiation regimen5,6, involves two injections of AOM 400 administered at separate injection sites (deltoid or gluteal muscle) plus a single dose of oral aripiprazole 20 mg1. With the AOM 400-TIS, all treatments are administered on the same day during a single clinic visit. Therapeutic drug levels are achieved on the first day of treatment7, removing the need for 14 days of oral aripiprazole supplementation.

Based on the authors’ own experience, uptake of the AOM 400-TIS was rapid in Italy, with a rate of adoption that exceeded that in other European countries. Potential reasons for this include the familiarity of Italian psychiatrists with AOM 400 and the perception that the AOM 400-TIS is a practical alternative to the traditional one-injection start. Notably, removing the requirement for 14 days of overlapping oral aripiprazole reduces the risk of adherence-related under-treatment and subsequent relapse during the initiation of therapy7. Related to this, the AOM 400-TIS reduces the burden on patients to remember to take oral medication for 14 days with their first injection of AOM 400, as well as any associated oversight needed from families or other caregivers7,8. In an inpatient setting, the AOM 400-TIS may allow for an earlier discharge, since the requirement for healthcare professionals (HCPs) to supervise multiple days of oral medication intake is removed7.

Recently, the results of a non-interventional, cross-sectional survey were published, offering an insight into the views and experiences of HCPs from 5 European countries who prescribe and/or administer the AOM 400-TIS.9 The survey included a notable number of participants from Italy, which could provide a unique opportunity to examine study outcomes from an Italian perspective. However, individual country-level data were not previously published. The results of an Italian-specific analysis are reported here, with author interpretation that places the findings in the context of Italian clinical practice.

Materials and methods

Survey objectives and design

A full and thorough description of the non-interventional, cross-sectional online survey has been reported previously9,10. In brief, HCPs from Germany, Italy, Denmark, Sweden, and the United Kingdom (UK) participated in the survey, which was conducted in two waves between February and November 20249. The primary aim of the survey was to assess HCPs’ experiences and satisfaction with the AOM 400-TIS10. Secondary aims were to: 1) examine the characteristics of HCPs who prescribe AOM 400-TIS; 2) identify patient and clinical factors that influence their decision to initiate treatment using the AOM 400-TIS; 3) assess their perceptions of the efficacy, safety, and tolerability of the AOM 400-TIS; and 4) gather broader insights into their views and experiences with the AOM 400-TIS10. The survey was developed with input from a steering committee of clinical experts to ensure that the content reflected real-world European practice and captured the relevant settings and specialities involved in prescribing or administering AOM 400-TIS10.

The survey comprised 28 questions and was designed to be completed in 15-20 minutes10. In most cases, participants were instructed to select one or more predefined response options depending on the nature of the question10. In answering the survey questions, participants were directed to reflect on their past experience with the AOM 400-TIS (administered according to their local label) in adult patients diagnosed with schizophrenia10. Full versions of the survey have been published previously in the supplementary appendices accompanying Fagiolini et al.10 and Beckham et al9.

The survey was conducted online and hosted on a secure web-based platform10. Participants completed the survey in their local language and received a modest and appropriate payment in their local currency as compensation for their time10. Data collection was pseudonymised, with each participant assigned a unique identification number to ensure confidentiality10. The survey underwent internal and external user testing prior to launch, including checks of a dummy dataset to confirm correct programming of filters and quotas. Data quality was monitored during the survey period using predefined quality control measures (e.g., identification of duplicate respondents, speeders, and flatliners), with formal data checks conducted at soft launch (5-10% of completers), at 50% completion, and once the full study sample had been achieved.

The study followed the ethical principles set out in the Declaration of Helsinki and met the requirements of the European Union General Data Protection Regulation10. Since the study involved only physician surveys and did not include patients or access to patient medical records, it was deemed exempt from Institutional Review Board (IRB) review (SALUS IRB; 14 January 2024)10. The completed Checklist for Reporting of Survey Studies can be found in the supplementary material.

Participant population and recruitment

Eligible participants were licensed physicians or nurses who were involved in the treatment and management of schizophrenia and who had prescribed and/or administered the AOM 400-TIS to patients diagnosed with schizophrenia on at least three occasions10. Employment by a pharmaceutical company was an exclusion criterion10.

Participant recruitment in Wave 1 of the study (1 February-21 March 2024 [participants from Germany, Italy, and the UK]) was via online panels of individuals who had been independently preselected by a recruiting agency, based on their likelihood to meet the study criteria and their prior interest in participating in research studies10. Participants were invited to participate until the pre-planned sample size was achieved. HCPs from the panels were randomly selected and provided a unique link to the survey information sheet10. Those meeting all study requirements and eligibility criteria, including provision of electronic consent, were invited to complete the survey10. All ineligible respondents were directed away from the survey10. Recruitment via online panels was also adopted in Wave 2 of the study (18 September-27 November 2024 [participants from Denmark, Sweden, and Italy]), with extra Italian participants recruited on a voluntary basis via email from the local network of the Italian member of the steering committee9.

Statistical analysis

Data were analysed descriptively on an item-by-item basis using Microsoft® Excel® 36510. The descriptive design of the study meant that a formal power calculation was not required10. Within the Italian sample, planned recruitment was 110 HCPs (Wave 1, n=30; Wave 2, n=80 [with up to n=50 recruited via online panels and up to n=30 recruited via the Italian steering committee member’s professional network])9. The target distribution of HCPs recruited via online panels across Waves 1 and 2 combined was approximately two physicians for every one nurse (i.e., 55 physicians [Wave 1, n=20; Wave 2, n=35] and 25 nurses [Wave 1, n=10; Wave 2, n=15])9. For HCPs recruited on a volunteer basis (Wave 2 only), there was no preplanned distribution of physicians versus nurses9. No formal inferential testing (e.g., chi-square or t-tests) was conducted.

Results

In total, 1501 HCPs based in Italy were invited to take part in the survey, 241 were screened (1260 did not respond), and 108 completed the survey; 133 HCPs were excluded; the main reasons for exclusion included screen failure (n=69) or incomplete survey (n=60). Of the 108 HCPs who completed the survey from Italy, 31 participated in Wave 1 and 77 participated in Wave 2 (recruited via online panels, n=51; recruited via email invite, n=26). The characteristics of the Italian participants are detailed in table 1.




The two most prevalent job roles were physician psychiatrist (68.5%) and psychiatric nurse (23.1%), while the two most common work environments were specialist mental health clinics/centres (76.9%) and hospital inpatient settings (25.9%). The Italian HCPs had worked professionally in clinical practice for a mean (standard deviation [SD]) of 19.7 (12.2) years. Within the HCP caseload, the mean (SD) proportion of patients with a diagnosis of schizophrenia was 35.5% (22.5%); of these, a mean (SD) of 43.7% (25.8%) were treated with LAI antipsychotics.

Table 2 outlines factors related to use of the AOM 400-TIS by Italian HCPs.




Nearly one-half of participants (45.4%) reported that they had been prescribing and/or administering the AOM 400-TIS for a period exceeding 24 months. The AOM 400-TIS was most frequently used in patients with moderate symptoms (68.5%), with no notable variation in use between those aged 18-35 years (67.6%) and those aged 36-64 years (69.4%).

The most frequently reported reasons that Italian HCPs chose to initiate treatment with the AOM 400-TIS in patients diagnosed with schizophrenia are shown in figure 1.




Of the available responses, ‘Poor treatment adherence’ was selected most frequently (81.5%), followed by ‘patient preference (i.e., patient not willing to take oral medication)’ (50.0%) and ‘relapse(s) of disease’ (42.6%).

The primary objectives cited by Italian HCPs when choosing to prescribe the AOM 400-TIS are outlined in figure 2, with the most common being ‘to improve adherence’ (74.1%), ‘to prevent relapses’ (67.6%), ‘to improve patient quality of life’ (QoL, 60.2%), and ‘to prevent re-hospitalisations’ (59.3%). When HCPs were prompted to identify the single most important objective when choosing to prescribe the AOM 400-TIS, ‘to improve adherence’ was selected most often (35.3%), followed by ‘to improve patient QoL’ (27.1%), ‘to prevent relapses’ (17.6%), and ‘to improve symptoms’ (11.8%).




The most frequently cited reasons and/or barriers to not use the AOM 400-TIS are displayed in figure 3.




The most commonly selected response was ‘patients don’t want two injections’ (36.1%), followed by ‘concerns around tolerability’ (24.1%), ‘concerns around safety of administering high dose on a single day’ (23.1%), and a ‘lack of clinical education’ (22.2%).

Patient and clinical factors that influenced HCPs’ decision to prescribe the AOM 400-TIS are shown in figure 4.




The top three responses were ‘adherence to prior treatment’ (55.6%), ‘efficacy’ (41.7%), and ‘safety/tolerability’ (41.7%). When asked to rank their responses in order of importance, HCPs most often selected ‘adherence to prior treatment’ (39.1%) and ‘efficacy’ (12.6%) as being most important (figure S1).

Wider views and experiences with the AOM 400-TIS

HCP responses to statements on their recent experience with the AOM 400-TIS are shown in figure 5.




Overall, 85.2% of HCPs agreed or strongly agreed that they were satisfied with the outcomes of patients who received the AOM 400-TIS, with 82.4% agreeing or strongly agreeing that the AOM 400-TIS was easy to administer. Collectively, 69.4% of HCPs agreed or strongly agreed that the AOM 400-TIS had a similar safety/tolerability profile to initiation with a single injection of AOM 400 plus 14 days of supplemental oral aripiprazole.

Discussion

The results of the current survey offer a valuable perspective on the real-world use of the AOM 400-TIS initiation regimen in Italy. Based on feedback from more than 100 physicians and nurses, data indicate that HCPs prescribe or administer the AOM 400-TIS to support treatment adherence, align with patient preferences, and reduce the risk of relapse. Reasons for not using the AOM 400-TIS include patient reluctance to receive two injections at the same time and safety or tolerability concerns.

Treatment adherence was a primary driver of AOM 400-TIS use. Specifically, poor treatment adherence was the most common reason that Italian HCPs used the AOM 400-TIS (81.5% of HCPs), improving adherence was the most common treatment objective (74.1%), and adherence to prior therapy was the most common patient/clinical factor influencing its use (55.6%). The survey did not collect data on the rationale behind HCPs’ responses, so reasons for the focus on adherence are unclear. However, therapeutic drug levels are rapidly achieved with the AOM 400-TIS6,7, without the need for 14 days of supplemental tablet taking. This removes the known vulnerability associated with missed oral doses in the early treatment phase, which could be advantageous in populations with known adherence challenges6,11.

Patient preference ranked above disease relapse as a reason for initiating maintenance treatment with the AOM 400-TIS in the Italian cohort. The focus on patient preference in Italy aligns with recent findings from other pan-European and North American qualitative interview studies, in which prescribers identified patient preference and buy-in as an important factor when prescribing an LAI, and a critical determinant of LAI treatment success12,13.

The most common reasons or barriers given for not using the AOM 400-TIS were that patients did not want two injections or that they had concerns around the tolerability or safety of administering a high dose on a single day. Based on the authors’ own clinical experiences, potential approaches to overcoming barriers to the AOM 400-TIS regimen may include framing the regimen positively as a means of reducing patient anxiety or resistance, with communication focused on simplification, reassurance, and the long-term benefits of stability and relapse prevention. The regimen may be framed as a ‘one-and-done’ approach that ensures immediate long-acting coverage without the burden of daily pills, a message that resonates well with patients, particularly younger individuals and those with prior difficulty adhering to oral treatment. It may also resonate well with patients with early-phase disease, a population for whom functional recovery is considered an important and achievable long-term treatment goal14. For illustration, one way of presenting it might be: ‘With this injection plan, you’re protected starting today, without needing to remember any pills tomorrow’. Emphasis can also be placed on the regimen being well tolerated, while providing rapid therapeutic coverage without the need for follow-up oral medication; findings that are supported by the scientific literature7,15. At the same time, it is important that decisions regarding the AOM 400-TIS are not imposed, but are instead developed collaboratively, taking into account any views or concerns that a patient may have about the regimen. This aligns with the previously mentioned qualitative interview studies, in which researchers emphasised the importance of shared decision-making and the need for prescribers to engage patients in conversation to explore any preconceptions they might have about LAIs12,13. This same approach is also relevant to patient-prescriber conversations about a TIS with Ari 2MRTU 960, an LAI formulation of aripiprazole monohydrate that is administered once every 2 months.

The data reported here add to already published real-world findings on the use of the AOM 400-TIS in clinical practice in Italy specifically. A retrospective review of 133 patients living with schizophrenia treated at ten Italian clinics found no notable safety concerns with the AOM 400-TIS15. Adverse events (AEs) within the first month were mild or moderate, and the safety profile of AOM 400-TIS was similar to that for AOM 400 in clinical trials15. Separately, the results of a European database study, which included patients from Italy, showed that real-world incidence rates for extrapyramidal AEs with AOM were compatible with those reported in clinical studies16, a finding that could alleviate any general hesitation in prescribing AOM. In a retrospective chart review of 24 inpatients in Italy who received the AOM 400-TIS, including 10 with psychosis or schizophrenia, most did not require hospital readmission (83.3%) or a subsequent emergency room visit (87.5%)17. Reporting on the AOM 400-TIS in Italy also extends to patients with concomitant substance use disorder (SUD). Investigators examined outcomes following initiation of AOM 400 using a one-injection start or the TIS in 152 patients with or without concomitant SUD11. No serious adverse events were reported, aside from one case of akathisia which resulted in treatment discontinuation in a patient without SUD who received the AOM 400-TIS; all other events were mild, transient, and required no intervention11. Although all patient groups showed improvements in psychopathology, the overall effect was greater with the AOM 400-TIS versus the one-injection start in those with concomitant SUD11.

Fewer than 20% of Italian HCPs cited a lack of reimbursement as a reason and/or barrier that might lead them to not use the AOM 400-TIS. There appear to be few administrative obstacles to accessing the AOM 400-TIS in Italy, including those related to pricing or formulary inclusion. At the time the survey was conducted, AOM 400 was reimbursed under the national healthcare system, with the reimbursement conditions for the TIS regimen being essentially the same as for the original LAI formulation. In some regions in Italy, a therapeutic plan signed by a psychiatrist may be required, but this is considered generally straightforward.

While the results presented here are specific to the AOM 400-TIS, they may offer insight into how Italian HCPs perceive a TIS involving Ari 2MRTU 960, the once-every-2-month LAI formulation of aripiprazole monohydrate. Ari 2MRTU 960 was approved in Europe in March 2024 for the maintenance treatment of schizophrenia in adult patients stabilised with aripiprazole1,18 (either oral aripiprazole or AOM), and can also be initiated using a TIS initiation regimen (i.e., one injection of Ari 2MRTU 960, one injection of AOM 400, and a single 20 mg dose of oral aripiprazole)1. Although real-world data on the Ari 2MRTU 960 TIS are currently lacking – reflecting the recency of the drug’s approval – it is plausible that the drivers and barriers identified for the AOM 400-TIS may also be relevant for the Ari 2MRTU 960 TIS. That said, between-treatment differences in the dosing interval and related follow-up schedule may shape initiation decisions differently.

General limitations of the survey have been reported previously9,10. Of note, participants comprised a convenience sample of HCPs recruited from existing panels who voluntarily participated in the survey, which introduces selection bias10; since invitations were not drawn from a national registry of Italian HCPs, the sample does not approximate a random sample of the underlying clinician population. Added to this, approximately one-quarter of Italian participants were recruited via the professional network of the Italian member of the steering committee, which may introduce further selection bias and limit the diversity and generalisability of responses.

Conclusions

The results of the current survey provide an insight into the views and experiences of more than 100 Italian HCPs who prescribe and/or administer the AOM 400-TIS in adults diagnosed with schizophrenia in real-world practice. Treatment adherence was a primary driver of AOM 400-TIS use, along with relapse prevention, and alignment with patient preferences. Perceived barriers to use of the AOM 400-TIS were patient reluctance to receive two injections at the same time and safety/tolerability concerns. Most HCPs agreed that the AOM 400-TIS was easy to administer, had a safety/tolerability profile similar to the one-injection start, and led to satisfactory patient outcomes.

Prior presentation: results have been published previously in poster format: Beckham C et al. Use and experience of Italian healthcare professionals with aripiprazole once-monthly 400mg two-injection start initiation regimen in adult patients with schizophrenia. Poster presented at: the 33rd European Congress of Psychiatry (EPA); 2025 Apr 5-8; Madrid, Spain [Poster EPV1559].

Acknowledgements: the authors would like to thank the HCPs that participated in the survey. They would also like to thank Global Perspectives who programmed and hosted the survey, and who recruited and invited participants to the study.

Medical writing support was provided by Lyndal Staples, BSc, and editorial support was provided by Isabella Cannava, BA, of the Prime Group of Companies (Knutsford, UK); this support was funded by Otsuka Pharmaceutical Europe Ltd. and H. Lundbeck A/S.

Funding: this work was sponsored by Otsuka Pharmaceutical Europe Ltd. (Windsor, United Kingdom) and H. Lundbeck A/S (Valby, Denmark).

Authorship and author contributions: all authors participated in the study conception and/or design, and data collection, analysis, and/or interpretation. All authors participated in the drafting or critical review of the article; gave final approval of the version to be published; and agree to be accountable for all aspects of this work.

Conflicts of interest: Murat Yildirim is an employee of H. Lundbeck A/S, Valby, Denmark. Clodagh Beckham was an employee of Otsuka Pharmaceutical Europe Ltd., Berkshire, United Kingdom, at the time the research was conducted. Sofia Pappa has acted as a consultant, speaker, or has received research grants from Lundbeck, Janssen, Otsuka, Recordati, Rovi, Gedeon Richter, Sunovion, and Teva. Karolina Leopold has participated on advisory boards and/or as a speaker, and/or has received research grants from Boehringer Ingelheim, Lundbeck, Janssen, Otsuka, Recordati, and Rovi. Joe Hickey is an employee of OPEN Health, London, United Kingdom, the contract research organisation that conducted the study. William J. Cottom and Olivia Rogerson were employees of OPEN Health, London, United Kingdom at the time the research was conducted. Andrea Fagiolini is a consultant and/or speaker and/or has received research grants from Angelini, Boehringer Ingelheim, Idorsia, Italfarmaco, Lundbeck, Janssen, Medicamenta, Mylan, Otsuka, Pfizer, Recordati, Rovi, Sunovion, Teva, and Viatris.










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