ArticleNeuropsychiatric disease and treatment2025
Aripiprazole Lauroxil Every 2 Months or Paliperidone Palmitate Monthly for Acute Schizophrenia: A Post Hoc Analysis of PANSS Five-Factor Scores in the ALPINE Trial.
Article in Neuropsychiatric disease and treatment, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03345979 (A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation), which is not on this map. Not yet cited in PubMed.
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A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation
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Abstract
Purpose: The randomized, controlled Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness (ALPINE) study (NCT03345979) evaluated the efficacy and safety of aripiprazole lauroxil (AL) administered every-2-months in patients with schizophrenia. Primary results indicating significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores with AL or active control (paliperidone palmitate [PP] monthly) were reported previously. In this post hoc analysis, treatment effects based on a PANSS five-factor model were assessed. Patients and Methods: Adult patients with an acute exacerbation of schizophrenia were enrolled as inpatients, randomized to AL (1064 mg every 2 months) or PP (156 mg monthly), discharged after 2 weeks, and then followed as outpatients through week 25. PANSS five-factor scores at baseline and weeks 4, 9, and 25 were analyzed in this post hoc analysis. Within-group changes from baseline were summarized by treatment group using the last-observation-carried-forward method for imputation; no formal testing of statistical significance was performed. Results: Of 200 patients randomized to AL (n=99) or PP (n=101), 99 patients (AL, n=56; PP, n=43) completed study treatment. Improvement in PANSS factor scores was observed with AL from baseline to week 25. Mean (standard error [SE]) changes at week 25 were -3.5 (0.42) (negative); -5.4 (0.56) (positive); -3.4 (0.39) (disorganized thought); -1.9 (0.32) (uncontrolled hostility/excitement); and -3.1 (0.37) (anxiety/depression). For PP, week 25 PANSS factor improvements (mean [SE]) for the negative, positive, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression factors were -3.4 (0.48), -6.0 (0.49), -4.0 (0.35), -2.2 (0.30), and -3.5 (0.41), respectively. Conclusion: In this post hoc analysis of patients with acutely exacerbated schizophrenia treated with AL 1064 mg every-2-months or PP 156 mg monthly, numerical improvements in PANSS five-factor scores were observed over time. These results support the primary efficacy findings based on PANSS total score and suggest that efficacy extends to these clinically important symptom domains.
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