NYMC Faculty Publications

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

Author Type(s)

Faculty

DOI

10.2147/NDT.S510471

Journal Title

Neuropsychiatric Disease and Treatment

First Page

1047

Last Page

1055

Document Type

Article

Publication Date

1-1-2025

Department

Psychiatry and Behavioral Sciences

Keywords

antipsychotic agents, symptom assessment, treatment efficacy

Disciplines

Medicine and Health Sciences

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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