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Psych Congress  

Efficacy of acute treatment with aripiprazole once-monthly on Marder factor scores in patients with schizophrenia

Authors  
Anna Eramo, MD
John Kane, MD
Maia Miguelez, PhD
Timothy Peters-Strickland, MD
Na Jin, MS
Pamela P. Perry, MS
Peter Hertel, PhD
Raymond Sanchez, MD
Robert McQuade, PhD
Zahinoor Ismail, MD, FRCPC
Sponsor  
Supported by Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S

Objective: Aripiprazole once-monthly 400 mg (AOM 400) demonstrated significant improvements in symptoms and functioning versus placebo, and good tolerability in patients with acute exacerbation of schizophrenia. This post-hoc analysis investigates effects of AOM 400 on a broad range of symptoms using the five Marder factors of the Positive and Negative Syndrome Scale (PANSS). Methods: In a randomized, double-blind, placebo-controlled 12-week study, AOM 400 was compared to placebo in adults with schizophrenia experiencing an acute psychotic episode. Primary and secondary outcomes, as well as safety and tolerability, have been published. The five PANSS Marder factors are well-validated and widely used to provide a complete representation of the symptom range in schizophrenia. Changes from baseline to week 12 in PANSS Marder factors were assessed using a mixed model of repeated measures. Results: Significant improvements on Marder factor scores with AOM 400 (n=162) vs placebo (n=167) were demonstrated by least squares mean (LSM) changes [95%CI] from baseline to week 12 of -4.5 [-6.0;-3.0] (p<0.0001) for positive symptoms, -2.5 [-3.8;-1.3] (p=0.0001) for negative symptoms, -3.4 [-4.7;-2.1] (p<0.0001) for disorganized thoughts, -2.4 [-3.3;-1.5] (p<0.0001) for uncontrolled hostility/excitement, -1.7 [-2.5;-0.8] (p=0.0002) for anxiety/depression, and -2.8 [-3.9;-1.8] (p<0.0001) for PANSS excited component (PEC). The improvements with AOM 400 vs placebo were significant from week 1-2 on all Marder factors, and remained significant through to endpoint. Conclusions: In acutely ill patients with schizophrenia, treatment with AOM 400 was efficacious and demonstrated fast and sustained onset of action across all domains of the illness conceptualized by PANSS Marder factors.

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