Abstract
This study aimed to investigate the factors that influenced the clinicians to adjust the paliperidone dose in the acute phase of schizophrenia. This was a post hoc study of an 8-week, open-label, single-arm multicenter trial which evaluated the efficacy, safety, and tolerability of flexible doses of paliperidone ER (3–12 mg/day) in patients with acutely exacerbated schizophrenia. Patients were divided into groups according to the dose at week 8 (3, 6, and 9–12 mg). The responder was defined as the reduction percentage in the Positive and Negative Syndrome Scale (PANSS) total score of ≥30%. According to the chi-squared automatic interaction detection algorithm, decision tree models predicting an increase in the dose of paliperidone ER were established. A decision tree, based on 4-week Marder positive factor, Clinical Global Impression (CGI), and BMI, was established to guide the dose adjustments of paliperidone ER in the acute phase of schizophrenia. The multivariable logistic regression analysis showed that lower age at onset, higher baseline PANSS positive subscale score, and lower baseline Personal and Social Performance Scale (PSP) score were significant predictors of increased dose in responders. Patients with young-onset age, severe baseline symptoms, and poor function are more likely to benefit from high dosage.
Highlights
Schizophrenia is a chronic and disabling mental disorder with serious physical, social, and economic consequences [1]
The results showed that 41.2% of participants who completed the 8-week trial remained on the initial dose of 6 mg/day, while the dose was increased in 54.6% of participants
The recommended initiation dose of paliperidone ER is 6 mg/day [1, 6], studies suggested that a dose higher than 6 mg could be more effective in selected patients [7, 18,19,20]
Summary
Schizophrenia is a chronic and disabling mental disorder with serious physical, social, and economic consequences [1]. Paliperidone is an antipsychotic drug for schizophrenia. It is an active metabolite of risperidone (9-OH risperidone) and has almost the same pharmacological profile, with a high affinity for the dopamine D2 receptor and the serotonin 5-hydroxytryptamine 2A receptor [5]. Studies suggested paliperidone extended-release (ER) with a starting dose of 6 mg once daily without titration [1, 6]. It is currently admitted that titration is necessary for some patients [7]. Still, adjusting the dose of paliperidone ER in patients with acute schizophrenia is poorly understood
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