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In clinically stable adults with schizophrenia, aripiprazole 2-month ready-to-use 960 mg was generally well tolerated and showed efficacy comparable to aripiprazole once-monthly 400 mg over 32 weeks. Patients in both groups remained clinically stable on PANSS, CGI-S, SWN-S, and CGI-I assessments, with minimal change from baseline and minimal differences between groups. Study completion was 79.3% (73/92) with aripiprazole 2-month ready-to-use 960 mg and 67.7% (63/93) with aripiprazole once-monthly 400 mg, although this difference was not statistically significant (P = .0954).

In this trial, aripiprazole 2-month ready-to-use 960 mg was given as a single gluteal intramuscular injection every 56 ± 2 days, with 4 injections scheduled over 32 weeks. Aripiprazole once-monthly 400 mg was given every 28 ± 2 days, with 8 injections scheduled over the same period. The injection volume was 3.2 mL for aripiprazole 2-month ready-to-use 960 mg and 2.0 mL for aripiprazole once-monthly 400 mg.

Yes. On average, patients treated with aripiprazole 2-month ready-to-use 960 mg remained clinically stable through week 32. The mixed model for repeated measures analysis showed minimal change from baseline in PANSS total, CGI-S, and SWN-S scores, with minimal differences between the 2-month and once-monthly aripiprazole groups. Mean (SD) CGI-I score at week 32 was 3.5 (1.0) with aripiprazole 2-month ready-to-use 960 mg and 3.6 (0.9) with aripiprazole once-monthly 400 mg.

Treatment-emergent adverse events were common but similar between groups. Overall, 66.3% of patients (61/92) receiving aripiprazole 2-month ready-to-use 960 mg and 63.4% of patients (59/93) receiving aripiprazole once-monthly 400 mg had a treatment-emergent adverse event. Most treatment-emergent adverse events were mild or moderate, and serious treatment-emergent adverse events occurred in 5 patients in each group.

The most frequently reported treatment-emergent adverse events were increased weight, injection site pain, akathisia, and insomnia. The article states that the incidence of increased weight, akathisia, and insomnia was comparable between aripiprazole 2-month ready-to-use 960 mg and aripiprazole once-monthly 400 mg. None of the cases of increased weight, injection site pain, or insomnia were considered severe or serious by the investigator.

Potentially clinically significant weight gain of at least 7% was reported in 39.7% of patients treated with aripiprazole 2-month ready-to-use 960 mg (29 of 73 patients with post-baseline weight data) and 38.1% of patients treated with aripiprazole once-monthly 400 mg (24 of 63; P = .8619). The study found no meaningful difference between groups in this outcome.

Injection site pain was somewhat more frequent numerically with aripiprazole 2-month ready-to-use 960 mg, but the between-group difference was not statistically significant. Injection site pain occurred in 15.2% of patients (14/92) with aripiprazole 2-month ready-to-use 960 mg and 9.7% of patients (9/93) with aripiprazole once-monthly 400 mg (P = .2740). All injection site pain events were rated mild or moderate, occurred within 2 days of injection, and mean pain scores on a 0-100 visual analog scale were low in both groups.

Mean injection pain scores were low with both formulations. For aripiprazole 2-month ready-to-use 960 mg, mean (SD) visual analog scale pain scores were 3.9 (9.96) after the first injection and 1.5 (4.58) after the last injection. For aripiprazole once-monthly 400 mg, the corresponding scores were 2.9 (5.40) and 1.3 (2.79), with no significant between-group difference after the first injection (P = .3859) or the last injection (P = .7427).

Motoric treatment-emergent adverse events were reported in 15.2% of patients (14/92) receiving aripiprazole 2-month ready-to-use 960 mg and 11.8% of patients (11/93) receiving aripiprazole once-monthly 400 mg (P = .5265). Akathisia was the most frequent motoric adverse event, occurring in 8.7% (8/92) and 7.5% (7/93) of patients, respectively. The study also found no notable improvement or decline from baseline in motoric rating scale scores in either group.

For patients stabilized on oral antipsychotic treatment, the trial used 7 days of overlapping oral antipsychotic treatment after the first aripiprazole 2-month ready-to-use 960 mg injection. The corresponding overlap period was 14 days after the first aripiprazole once-monthly 400 mg injection. There was no oral overlap for participants who were already stabilized on aripiprazole once-monthly 400 mg.

The schizophrenia analysis included 185 clinically stable adults with schizophrenia enrolled at 16 US sites and randomized to aripiprazole 2-month ready-to-use 960 mg (n = 92) or aripiprazole once-monthly 400 mg (n = 93). Eligible patients were 18-64 years old, had a DSM-5 diagnosis of schizophrenia, were in good physical health, and had been clinically stable on an atypical antipsychotic for at least 2 months before screening. Patients with current acute relapse, treatment resistance, recent substance use disorder, significant suicide risk, or a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia were excluded.

This was a randomized, open-label, multiple-dose, parallel-arm, multicenter trial, and this report was a post hoc secondary analysis of the schizophrenia subgroup. Safety was the primary objective, while efficacy was a secondary objective assessed mainly by whether patients remained stable rather than improved. Because the study enrolled clinically stable patients and was not powered to show statistical significance for change from baseline in efficacy outcomes, the results are most useful for interpreting maintenance safety, tolerability, and preservation of symptom stability.

The authors identified several important limitations. The study was open-label, was not powered to show statistical significance of change from baseline in efficacy outcomes, and was conducted only in the United States. In addition, the population consisted of clinically stable patients with schizophrenia, so the findings apply to maintenance treatment rather than acute symptom stabilization.

This study supports aripiprazole 2-month ready-to-use 960 mg as a maintenance option for clinically stable patients with schizophrenia. The trial enrolled patients who were already stable at baseline, and efficacy outcomes showed maintenance of that stability over 32 weeks rather than symptomatic improvement. The authors also noted that no trend was observed for schizophrenia symptoms emerging toward the end of the 2-month dosing interval.