A Multicenter Retrospective Study to Analyse the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Patients With Schizophrenia in Portugal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M Treatment
研究概览
简要总结
The purpose of this study is to investigate the mean number of schizophrenia-related hospital admissions, in adult participants with schizophrenia, occurred during 12 months before and 12 months after initiation of Paliperidone Palmitate 1-month formulation treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a confirmed diagnosis schizophrenia according to the International Classification of Diseases (ICD) 9th Edition codes, or the correspondent ICD-10 codes if applicable
- •Must have been treated with oral antipsychotics (OAPs) and who switched to paliperidone palmitate 1-month formulation (PP1M) due to poor adherence, or lack of efficacy (no significant symptom reduction, as judged by the treating physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants' choice, or unknown reason when the switch has not been clearly justified
- •Had been treated with OAPs for at least 12 months prior to switching to PP1M. During the treatment with OAPs, dose adjustments were allowed. Participants should have been treated with PP1M for at least 4 consecutive months after the switch
- •Must have available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment during the observation period, and with the indication of PP1M initiation in their medical charts
- •Must be being treated at an ambulatory setting at study entry
排除标准
- •Participants with schizophrenia resistant to treatment (TR). TR is defined for the purpose of this study by at least two failed adequate trials with different antipsychotics (at maximal antipsychotic efficacious label dose for 4 to 6 consecutive weeks)
- •Participants that used clozapine as treatment for schizophrenia in any given period prior to or during the observation period, independently of other concomitant psychotropic medication
- •Participants who have participated in a clinical trial during the observation period
- •Participants that switched to PP1M before the 31st of July 2014, that is in the first 6 months after it was available for reimbursement in Portugal
研究组 & 干预措施
Participants with Schizophrenia
Participants diagnosed with schizophrenia who switched from oral antipsychotics (OAPs) to Paliperidone Palmitate 1-month formulation (PP1M), with available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment, and who switched to PP1M at least 6-months after it was available for reimbursement in Portugal will be observed. The primary data source for this study will be the medical records of each participant.
干预措施: Oral Antipsychotics (OAPs) (Drug)
Participants with Schizophrenia
Participants diagnosed with schizophrenia who switched from oral antipsychotics (OAPs) to Paliperidone Palmitate 1-month formulation (PP1M), with available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment, and who switched to PP1M at least 6-months after it was available for reimbursement in Portugal will be observed. The primary data source for this study will be the medical records of each participant.
干预措施: Paliperidone Palmitate 1-Month Formulation (PP1M) (Drug)
结局指标
主要结局
Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M Treatment
时间窗: Approximately 12 months
Mean number of schizophrenia-related hospital admissions occurred during 12 months of oral antipsychotics (OAP) treatment prior to initiation of Paliperidone Palmitate 1-Month Formulation (PP1M) treatment will be reported. Mean number of Schizophrenia-related hospital admissions will be calculated as: number of hospital admissions divided by total number of participants.
Mean Change of Schizophrenia-Related Hospital Admissions Between Periods
时间窗: Approximately 24 months
Mean change of schizophrenia-related hospital admissions occurred between periods (during 12 months of OAP treatment prior and 12 months after initiation of PP1M treatment) will be reported.
Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months After Initiation of PP1M Treatment
时间窗: Approximately 12 months
Mean number of schizophrenia-related hospital admissions occurred during 12 months after initiation of PP1M treatment will be reported. Mean number of Schizophrenia-related hospital admissions will be calculated as: number of hospital admissions divided by total number of participants.
次要结局
- Mean Number of Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M and During 12 Months After Initiation of PP1M Treatment for the Subgroup of Participants that Completed 12 Months of PP1M Treatment(Approximately 24 months)
- Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants That Discontinued Before Completing 12 Months of PP1M Treatment(Approximately 24 months)
- Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants that Completed 12 Months of PP1M Treatment(Approximately 24 months)
- Mean Number of Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M and During 12 Months After Initiation of PP1M Treatment for the Subgroup of Participants that Discontinued Before Completing 12 Months of PP1M Treatment(Approximately 24 months)
- Mean Length of Hospitalizations(Approximately 24 months)
- Mean Change in Length of Hospitalizations Between Periods(Approximately 24 months)
- Mean Cumulative Length of Hospitalizations(Approximately 24 months)
- Mean Change in Cumulative Length of Hospitalizations Between Periods(Approximately 24 months)
- Percentage of Participants Hospitalized(Approximately 24 months)
- Change in Percentages of Participants Hospitalized Between Periods (Hospitalization Reduction Percentage)(Approximately 24 months)
- Percentage of Outpatient Psychiatric Consultations(Approximately 24 months)
- Change in Percentage of Outpatient Psychiatric Consultations Between Periods(Approximately 24 months)
- Percentage of Relapse with Different Causes(Approximately 24 months)
- Change in Percentages of Relapse Between Periods with Different Causes(Approximately 24 months)
- Percentage of Participants who Discontinued PP1M Treatment with Different Reasons for Discontinuation Before and After Completing 12 Months of Treatment(Approximately 24 months)
- Hospitalization Rate per Patient-Years(Approximately 24 months)
- Mean Number of Emergency Psychiatric Visits(Approximately 24 months)
- Mean Change in Emergency Psychiatric Visits Between Periods(Approximately 24 months)