RECONNECT-S GAMMA : A Non-interventional Study to Observe Real-life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Description of used atypical antipsychotic(s) during hospitalisation
研究概览
简要总结
This is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode.
In this NIS subject's data will be collected at one visit at the moment of discharge from the hospital.
The results of the study would help to characterise the discrepancy between current clinical practice and treatment guidelines, indicating that atypical antipsychotics are preferable and should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia. Available evidence have revealed a frequent use of first-generation antipsychotics, polypharmacy, intramuscular route of administration and use of atypical antipsychotics in doses lower than recommended in registered summary of product characteristics.
详细描述
RECONNECT-S GAMMA : A non-interventional study to observe real-life usage of atypical antipsychotics in the acute inpatient management of schizophrenia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent has been obtained from the Subject and/or his/her legal representative (as per local regulatory requirements).
- •Meet the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- •Subject is hospitalised due to an acute psychotic episode
排除标准
- •Current participation in any clinical trial.
- •Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period)
结局指标
主要结局
Description of used atypical antipsychotic(s) during hospitalisation
时间窗: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
Description of the daily dosage of atypical antipsychotic(s) during hospitalisation
时间窗: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
Description of mode of administration of atypical antipsychotic(s) during hospitalisation
时间窗: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
次要结局
- Percent of patients with atypical antipsychotic as monotherapy(hospitalisation period, an expected average of 2 weeks (variable per patient))
- Percent of patients with combinations of antipsychotics.(hospitalisation period, an expected average of 2 weeks (variable per patient))
- Description of main criteria used for selection of an antipsychotic during hospitalisation.(hospitalisation period, an expected average of 2 weeks (variable per patient))
- Description of the usage of psychometric scales in day to day practice, to evaluate the disease symptoms and thus the efficacy of treatment.(hospitalisation period, an expected average of 2 weeks (variable per patient))
- Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization(hospitalisation period, an expected average of 2 weeks (variable per patient))
- Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge(hospitalisation period, an expected average of 2 weeks (variable per patient))
- Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health.(hospitalisation period, an expected average of 2 weeks (variable per patient))