Objective: Assess the effect of aripiprazole once-monthly 400 mg (AOM 400), an extended-release injectable suspension of aripiprazole, on the patient reported outcome scales Subjective Well-being under Neuroleptic Treatment - short version (SWN-S), and the Drug Attitude Inventory (DAI). The primary outcome showed significantly lower psychiatric hospitalizations after switching to AOM 400 compared with their retrospective rates when treated with standard of care (SoC) oral antipsychotics (2.7% [n=9/336] vs 27.1% [n=91/336], respectively; P<0.0001).
Methods: Multicenter, open-label, mirror-image, naturalistic study in patients with schizophrenia. The prospective phase comprised a conversion period (1 to 4 weeks) for cross-titration from current oral antipsychotic SoC to oral aripiprazole monotherapy, and a 24-week, open-label phase (Phase B) where patients were treated with AOM 400. Within group mean changes from baseline in SWN-S and DAI at Week 12 and 24 of Phase B are reported using observed cases (OC).
Results: There were statistically significant improvements in SWN-S scores from baseline to Week 12 (n=255, baseline 86.2, change = +3.6, 95% CI 1.8,5.4, P=.0001) and to Week 24 (n=267, baseline 86.7, change +2.7, 95% CI 0.9 to 4.4, p=.004). There also were statistically significant improvements in DAI scores from baseline to Week 12 (n=255, baseline 19.2, change +1.1, 95% CI 0.1,2.0, P<.05) and to Week 24 (n=271, baseline 86.7, change +1.5, 95% CI 0.5 to 2.4, P=.002).
Conclusions: Improvements in the patient reported outcomes of wellbeing and attitude toward medication after initiating aripiprazole once-monthly suggests potential increases in adherence, and may have contributed to reduced hospitalizations.