2026 ECNP Congress

PS01-1250

Efficacy and safety of long-acting aripiprazole 960 mg: preliminary findings from a real-world longitudinal study

Edoardo Grechi — M. Olivola, T. prodi, R. Leuzzi, M. Biseo, N. Girone, C. Galimberti, C. Di Genova, K. La Monica, F. Calorio, E. Zuliani, G. Versaci, P. Gallazzi, N. kereszteny, M. Franchini, A. Crippa, G. Termine, R. anniverno, A. Cattaneo, B. Dell'Osso · University of Milan, Department of Pharmacological and Biomolecular Sciences- University of Milan- Milan- Italy., Milano, Italy

2026 ECNP Congress

Introduction

Treatment non-adherence is a primary driver of relapse and rehospitalization in schizophrenia spectrum disorders and bipolar disorder (BD), worsening illness course, increasing treatment resistance, and raising all-cause mortality rates [1, 2]. Long-acting injectable (LAI) antipsychotics represent an established strategy to overcome this challenge. In 2023, a two-month ready-to-use (2MRTU) 960 mg formulation of aripiprazole (Ari 2MRTU) was introduced, potentially improving adherence by halving the frequency of healthcare visits compared with monthly LAI formulations [3].

Aim

The aim of this prospective, longitudinal, real-world study was to evaluate the preliminary efficacy and safety of Ari 2MRTU in an outpatient clinical setting.

Methods

A total of 43 patients (≥18 years) receiving Ari 2MRTU were recruited from six Community Mental Health Centers (CMHCs) in Milan and Voghera, Italy, between September 2025 and January 2026. Diagnoses were established using the Structured Clinical Interview for DSM-5 (SCID-5). Evaluations were conducted at baseline (T0), 2-month follow-up (T1), and 4-month follow-up (T2). Efficacy was assessed using the Positive and Negative Syndrome Scale (PANSS) [4], the Montgomery–Åsberg Depression Rating Scale (MADRS), and the Young Mania Rating Scale (YMRS). Safety and acceptability were evaluated through the UKU-PAT, ADTQ, DAI-10, EQ-5D VAS, and Compliance Rating Scale (CRS). Longitudinal changes were analyzed using linear mixed-effects regression (LMER) models, accounting for time, age, sex, and previous oral aripiprazole treatment. Continuous variables were described using medians and interquartile ranges (IQR).

Results

The sample comprised 43 subjects (median age: 37 years [IQR: 30.00–52.50]; 53.49% male); 38 were evaluated at T1 and 23 at T2. PANSS total scores significantly decreased at both T1 (median: 46.50 [IQR: 36.25–64.00]) and T2 (48.50 [39.00–64.50]) compared to baseline (52.00 [40.50–76.00]; p<.05 both). PANSS positive symptom subscale scores significantly decreased at T1 and T2 (p<.05 and p<.01, respectively), with older age and male sex associated with higher scores (p<.05 both). PANSS negative symptom subscale scores showed a significant reduction at T2 only (p<.05). PANSS general psychopathology subscale scores did not reach statistical significance at either timepoint. MADRS scores significantly decreased at T1 (p<.05) but not at T2. No significant changes in YMRS scores were observed. Safety measures indicated a stable or slightly improved pattern of treatment acceptability, with no clinically relevant safety concerns or unexpected adverse reactions [5]. The proportion of patients agreeing that the formulation could support adherence increased from 37.21% at T0 to 60.87% at T2.

Conclusions

These preliminary findings suggest that Ari 2MRTU is associated with significant improvements in psychotic symptoms over 4 months, while depressive symptom changes were only partially significant and manic symptom scores remained stable. The formulation showed a favorable safety and acceptability profile. Given the observational design, small sample size, and short follow-up, results should be interpreted cautiously. Larger multicentric studies with extended follow-up are needed to confirm these findings.

Disclosure: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The authors declare no conflicts of interest.

References

References

  1. García, S., Martínez-Cengotitabengoa, M., López-Zurbano, S., Zorrilla, I., López, P., Vieta, E., González-Pinto, A., 2016. Adherence to Antipsychotic Medication in Bipolar Disorder and Schizophrenic Patients: A Systematic Review. J. Clin. Psychopharmacol. 36 (4), 355–371. https://doi.org/10.1097/JCP.0000000000000523
  2. Correll, C.U., Bookhart, B.K., Benson, C., Liu, Z., Zhao, Z., Tang, W., 2026. Association of antipsychotic nonadherence with all-cause mortality in adults with schizophrenia. Eur. Neuropsychopharmacol. 104, 112745. https://doi.org/10.1016/j.euroneuro.2025.112745
  3. Harlin, M., Yildirim, M., Such, P., Madera-McDonough, J., Jan, M., Jin, N., Watkin, S., Larsen, F., 2023. A Randomized, Open-Label, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable. CNS Drugs 37 (4), 337–350. https://doi.org/10.1007/s40263-023-00996-8