2026 ECNP Congress

PS04-4242

Switching to the novel 2-month Aripiprazole 960 mg in real-world: universal efficacy across other LAIs and oral transitions

Giuseppe Albanesi — G. Trovini, G. Lombardozzi, Y. Sonnino, V. Giovanetti, E. Amici, G. Civita, M. Manganozzi, D. Donato, A. Sabatino, C. Aiello, P. Clemente, A. Mirabella, S. Pompili, S. De Filippis · Villa Von Siebenthal Neuropsychiatric Hospital and Clinic, Department of Neuropsychiatry, Genzano di Roma, Italy

2026 ECNP Congress

Background

Long-Acting Injectable (LAI) antipsychotics are a cornerstone in the maintenance treatment of severe psychiatric disorders, enhancing adherence and preventing relapse [1]. The Aripiprazole 2-month ready-to-use (2M-RTU) 960 mg formulation offers the potential to further reduce administration frequency and treatment burden [2, 3, 4]. However, comprehensive real-world data regarding its clinical efficacy and, crucially, the outcomes of direct switching from other LAI formulations are scarce. Addressing clinicians’ concerns about potential destabilization during LAI transitions is essential for optimizing therapeutic strategies.

Aim of the study

This study aimed to evaluate the early real-world clinical trajectory of patients treated with the novel Aripiprazole 2M-RTU 960 mg, specifically comparing the 4-month psychopathological outcomes of patients directly switched from another LAI formulation versus those transitioned from oral regimens. The goal is to demonstrate the efficacy of the drug regardless of the previous therapeutic regimen, ensuring a safe transition for patients.

Methods

We conducted an analysis of preliminary findings from an ongoing Italian multicenter observational study, coordinated by the Villa Von Siebenthal Neuropsychiatric Hospital. The current real-world cohort comprises 75 patients (39 females, 36 males; mean age 38.3 ± 13.1 years) who initiated treatment with Aripiprazole 2M-RTU 960 mg. The sample was stratified into two distinct subgroups: patients switching directly from another LAI (n = 27) and patients transitioning from oral therapies (n = 48). Psychopathological severity was assessed at baseline, month 1, 2, and 4 utilizing the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impression-Severity scale (CGI-S). To compare the clinical trajectories and efficacy trends between the two groups over time, Repeated Measures General Linear Models (GLM) were applied.

Results

The overall cohort exhibited substantial clinical impairment at baseline (mean BPRS = 54.51; mean CGI-S = 4.47). Over the 4-month observation period, the entire sample demonstrated a marked and rapid clinical improvement. By Month 4, the BPRS total score significantly decreased (p < 0.001) by an average of 18.10 points in the oral therapy group and 14.16 points in the LAI switch group. Crucially, Repeated Measures GLM analysis revealed no statistically significant differences in the improvement trends between the two groups for both the BPRS (p = 0.912) and the CGI-S (p = 0.201). This progressive reduction in symptom severity was consistently maintained across all evaluation timepoints, confirming the early stabilizing effect of the 960 mg formulation regardless of the pre-existing treatment regimen.

Conclusion

The novel Aripiprazole 2M-RTU 960 mg formulation demonstrates rapid and robust psychopathological stabilization in a real-world clinical setting. Crucially, our findings highlight a universal trajectory of continuous clinical improvement, proving that aripiprazole 960 mg can be safely and effectively initiated whether a patient is transitioning from oral therapies or switching directly from another LAI. Ultimately, this formulation offers a vital dual clinical advantage over previous regimens: it enhances patient acceptability and adherence by requiring only six injections per year, while simultaneously providing clinicians with a reliable tool to secure a guaranteed two-month pharmacological coverage, a paramount asset when managing individuals with historically poor compliance.

References

  1. Kishimoto, T., Hagi, K., Kurokawa, S., Kane, J. M., & Correll, C. U. (2021). Long-acting injectable versus oral antipsychotics for the maintenance treatment of schizophrenia: a systematic review and comparative meta-analysis of randomised, cohort, and pre-post studies. The lancet. Psychiatry, 8(5), 387–404. https://doi.org/10.1016/S2215-0366(21)00039-0
  2. Harlin, M., Yildirim, M., Such, P., Madera-McDonough, J., Jan, M., Jin, N., Watkin, S., & Larsen, F. (2023). A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder. CNS drugs, 37(4), 337–350. https://doi.org/10.1007/s40263-023-00996-8
  3. 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 in a Randomized, Open-label, Parallel-Arm, Pivotal Study. The Journal of clinical psychiatry, 84(5), 23m14873. https://doi.org/10.4088/JCP.23m14873
  4. McIntyre, R. S., Such, P., Yildirim, M., Madera-McDonough, J., 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 bipolar I disorder in a randomized, open-label, parallel-arm, pivotal study. Current medical research and opinion, 39(7), 1021–1030. https://doi.org/10.1080/03007995.2023.2219155