An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study)

<b>Objectives:</b> To evaluate clinical evolution of patients with schizophrenia admitted in acute units because of a relapse and treated with once-monthly Paliperidone Palmitate (PP1M). <b>Methods:</b> This multicentre, open-label, prospective observational study followed patients with schizophrenia treated with PP1M in acute psychiatric units for up to 6 weeks. <b>Results:</b> Out of the 280 enrolled patients, 61 received PP1M as antipsychotic monotherapy, and 219 in combination with other antipsychotics. The average Clinical Global Impression–Schizophrenia (CGI-SCH) score decreased from 4.7 at baseline to 3.3 at final visit (<i>p</i> p <b>Conclusions:</b> PP1M was effective and well tolerated in treatment of acute episodes of schizophrenia both in monotherapy and in combination with other antipsychotics in clinical setting. Early start of PP1M therapy in acute schizophrenia episodes might help to shorten hospital stay.

【研究目标】：本研究旨在评估因精神分裂症复发入住急性精神科病房、接受每月一次棕榈酸帕利哌酮（once-monthly Paliperidone Palmitate，PP1M）治疗的患者的临床转归情况。【研究方法】：本项多中心、开放标签、前瞻性观察性研究，对急性精神科病房内接受PP1M治疗的精神分裂症患者开展最长6周的随访观察。【研究结果】：本研究共纳入280例入组患者，其中61例采用PP1M作为抗精神病单药治疗方案，219例联合其他抗精神病药物治疗。患者的精神科临床总体印象量表（Clinical Global Impression–Schizophrenia，CGI-SCH）平均得分从基线时的4.7降至末次随访时的3.3。【研究结论】：临床实践中，无论采用单药治疗还是联合其他抗精神病药物，PP1M用于治疗精神分裂症急性发作均具有良好疗效与耐受性。在精神分裂症急性发作早期启动PP1M治疗，或可缩短患者住院时长。