2026 ECNP Congress

EP02-2073

Real-world effectiveness, safety and tolerability of aripiprazole 2-month ready-to-use 960 mg: an 18-month follow-up study in outpatients with schizophrenia

Samuel Leopoldo Romero Guillena — G. Rodriguez Menendez, R.M. Ramallo Castillo, A. Torres Calleja, J.H. Jimenez Hernandez, A. Eslava Martin · U.S.M.C Carmona. UGC Mental Health Virgen Macarena, Psychiatry, Seville, Spain

2026 ECNP Congress

Introduction

Patients with schizophrenia frequently experience recurrent relapses, which are associated with progressive deterioration in psychopathology and functional outcomes. Preventing relapse remains a central goal of long-term management, and sustained antipsychotic treatment reduces relapse risk. However, suboptimal adherence remains a major barrier in clinical practice and is associated with increased rates of relapse, hospitalization, and suicidal behavior.

Long-acting injectable antipsychotics (LAIs) improve adherence and reduce relapse and hospitalization compared with oral formulations. [1,2,3]. Nevertheless, their use remains suboptimal in real-world settings, partly due to clinical inertia and discrepancies between randomized controlled trials and routine practice. Real-world evidence is therefore essential to better understand the effectiveness of LAIs under everyday conditions.

Extended-interval LAIs, including aripiprazole 2-month ready-to-use 960 mg, have been developed to enhance adherence and convenience by reducing dosing frequency while maintaining therapeutic plasma levels. [4,5]. Although clinical trials have demonstrated efficacy and tolerability, real-world data on this formulation remain limited, particularly regarding longer-term clinical outcomes in outpatient populations.

Objectives

To evaluate the real-world effectiveness, safety, and tolerability of aripiprazole 2-month ready-to-use 960 mg in patients with non-acute schizophrenia in an outpatient setting over 18 months of follow-up.

Methods

This prospective observational real-world study included 20 adult outpatients diagnosed with schizophrenia (DSM-5 criteria) who initiated treatment with aripiprazole 2-month ready-to-use 960 mg. Patients were followed for 18 months, with evaluations every 3 months. Assessments included Clinical Global Impression-Schizophrenia (CGI-SCH), insight measured with the G12 item of the Positive and Negative Syndrome Scale (PANSS-G12), treatment adherence, concomitant medication use, and safety outcomes.

Clinical outcomes included hospitalization, emergency department visits, and suicide attempts. Biological assessment included changes in neutrophil-to-lymphocyte ratio (NLR). The primary outcome was the proportion of patients remaining free from hospitalization. Secondary outcomes included the proportion without emergency visits or suicide attempts, changes in CGI-SCH, PANSS-G12 and NLR, treatment adherence, antipsychotic monotherapy, and tolerability.

Results

At 18 months, 85% of patients remained free from hospitalization, 80% had no emergency department visits, and 95% reported no suicide attempts. Treatment persistence was 80%, with three patients discontinuing due to preference for deltoid administration and switching back to the once-monthly formulation.

Significant improvements from baseline were observed in clinical severity and insight, with reductions in CGI-SCH (−1.18 ± 0.61; p < 0.01) and PANSS-G12 (−0.32 ± 0.27; p < 0.01). NLR also decreased significantly (−0.49 ± 0.32; p < 0.05). The proportion of patients receiving antipsychotic monotherapy increased from 70% at baseline to 90% at study completion.

Treatment was well tolerated, with transient mild insomnia (20%) as the most frequent adverse effect and no severe adverse events.

Conclusions: In this real-world outpatient sample, aripiprazole 2-month ready-to-use 960 mg was associated with high treatment persistence, favorable relapse-related outcomes, improved clinical severity and insight, and good tolerability over 18 months. These findings support the potential value of extended-interval LAIs in schizophrenia maintenance treatment, particularly for improving adherence and reducing healthcare utilization. Larger controlled studies are needed to confirm these results

References

  1. Leucht, S., et al., 2024. Oral versus long-acting injectable antipsychotics in schizophrenia: updated systematic review and meta-analysis. Lancet Psychiatry.
  2. Taipale, H., et al., 2024. Real-world effectiveness of long-acting injectable antipsychotics versus oral antipsychotics in schizophrenia. Am. J. Psychiatry.
  3. Wang, D., Schneider-Thoma, J., Siafis, S., Qin, M., Wu, H., Zhu, Y., Davis, J.M., Priller, J., Leucht, S., 2024. Efficacy, acceptability and side-effects of oral versus long-acting injectable antipsychotics: a systematic review and network meta-analysis. Eur. Neuropsychopharmacol. 83, 11-18.
  4. Correll, C.U., et al., 2025. Long-acting injectable antipsychotics: advances in extended dosing intervals and clinical outcomes. Eur. Neuropsychopharmacol.
  5. Citrome, L., Such, P., Yildirim, M., Madera-McDonough, J., Beckham, C., Zhang, Z., Larsen, F., Harlin, M., 2023. Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with schizophrenia. J. Clin. Psychiatry 84 (5), e23m14873