NCT05633108已完成不适用
A Retrospective Observational Study Based on the French National Health Insurance Database to Describe Antipsychotic Monotherapy and Polypharmacy Use, Including Loxapac, and to Investigate Their Association With Psychiatric Rehospitalization in Patients With Psychotic Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 579,728
- 试验地点
- 1
- 主要终点
- Time from Discharge from a Psychiatric Hospitalization to the Next Psychiatric Rehospitalization
研究概览
简要总结
The primary purpose of the study is to compare therapy with antipsychotic medication (antipsychotic monotherapy or antipsychotic combination) versus no antipsychotic medication, and antipsychotic monotherapy versus antipsychotic combination, regarding time to psychiatric rehospitalization, in participants with a psychotic disorder (that is, schizophrenia, schizotypal disorders, schizoaffective disorders, persistent or acute or induced or non-organic delusional disorders, recurrent depressive disorder with psychotic symptoms).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one discharge for psychiatric hospitalization with a diagnosis of a psychotic disorder between January 1, 2014 and December 31,
- •At least one long-term disease record (LTD), (which is a French administrative status allowing the full reimbursement of the cost of a chronic pathology) with a diagnosis of a psychotic disorder between January 1, 2014 and December 31,
- •Age of 18 years or older at index date (first date found in the previous conditions).
排除标准
- •Due to data management constraint, the participants with multiple or temporary identifiers in the database (indistinguishable in database) will be excluded. This happens with twins or migrants, for example.
结局指标
主要结局
Time from Discharge from a Psychiatric Hospitalization to the Next Psychiatric Rehospitalization
时间窗: From 1 January 2014 to 31 December 2020
Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first.
次要结局
- Cumulative Duration of Anti-Psychotic Biotherapy(From 1 January 2014 to 31 December 2020)
- Duration of Loxapac Treatment(From 1 January 2014 to 31 December 2020)
- Percentage of Days Covered (PDC) With Loxapac Treatment(From 1 January 2014 to 31 December 2020)
- Number of Participants With Consultations Based on a Hospital Psychiatrists, General Practitioner, Private Psychiatric Practitioner or Other Private Specialist(From 1 January 2014 to 31 December 2020)
- Number of Participants With Passage Through Emergency Department of Hospital(From 1 January 2014 to 31 December 2020)
- Cumulative Duration of Periods Without any Antipsychotic Treatment(From 1 January 2014 to 31 December 2020)
- Percentage of Participants Using Loxapac as Monotherapy or With Other Antipsychotic Polypharmacy Medication(From 1 January 2014 to 31 December 2020)
- Number of Participants With Hepatic, Glycaemia, Cardiovascular, Lipidic Anomalies Assessments(From 1 January 2014 to 31 December 2020)
- Number of Participants With Loxapac Treatment Episodes(From 1 January 2014 to 31 December 2020)
- Number of Participants With Off-drug Loxapac Treatment Period(From 1 January 2014 to 31 December 2020)
- Medical Possession Ratio (MPR)(From 1 January 2014 to 31 December 2020)
- Fixed Medical Possession Ratio (FMPR)(From 1 January 2014 to 31 December 2020)
- Number of Participants Categorized Based on all Hospitalizations, Psychiatric and Other Hospitalizations(From 1 January 2014 to 31 December 2020)
- Cumulative Duration of Loxapac as Monotherapy(From 1 January 2014 to 31 December 2020)
- Cumulative Duration of an Atypical/Typical Antipsychotic Drug Taken as Monotherapy Other Than Loxapac(From 1 January 2014 to 31 December 2020)
- Cumulative Duration of Loxapac and an Atypical/Typical Antipsychotic Therapy(From 1 January 2014 to 31 December 2020)
- Cumulative Duration of Other Antipsychotic Polypharmacy(From 1 January 2014 to 31 December 2020)
- Number of Participants Using Different Antipsychotic Medications(From 1 January 2014 to 31 December 2020)
研究者
研究点 (1)
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