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临床试验/NCT04358042
NCT04358042终止不适用

PSYCHIatric Disorders and Covid-19 (PSYCHIC) : Observatory of the Psychiatric, Somatic and Pharmacological Impacts of the COVID-19 Pandemic on Patients Hospitalized for Psychiatric Disorders and Suspected to be Infected by COVID-19

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
1
主要终点
impact of the COVID-19 pandemic on psychiatric symptomatology

研究概览

简要总结

Given the possible risks and complications of a comorbidity between psychiatric disorder and coronavirus disease 2019 (COVID-19), it seems particularly important to specify the impact of the COVID-19 pandemic in patients with psychiatric disorders and suspected of infection, hospitalized in a specific unit, at the psychiatric, somatic and pharmacological level.

详细描述

COVID-19's possible impact on psychiatric disorders has been little studied. However, patients with psychiatric disorders may be at higher risk of COVID-19 contamination, may experience delayed treatment when infected, may have a poor prognosis in terms of complications and success of treatment for COVID-19 but also for the underlying psychiatric disorder which could be exacerbated, and finally their psychotropic pharmacological treatment could be impacted by the inflammatory state linked to COVID-19.

The present study is an observatory of patients with psychiatric disorders and suspected to be infected by the COVID-19, hospitalized in a specific unit dedicated to the treatment of this comorbidity in the University Hospital of Nantes (France). The primary objective is to investigate the impact of the COVID-19 pandemic on the level of acute traumatic stress response. Secondary objectives include: (i) a description of the sample included; (ii) an assessment of the clinical evolution of these patients 4-6 weeks after admission; (iii) to investigate the links between the levels of stress, peritraumatic distress, and traumatic stress (whether it is acute or has evolved into a post-traumatic stress disorder (PTSD)); (iv) to investigate the links between resilience and coping on the one hand, and stress, peritraumatic distress and traumatic stress (acute or PTSD) on the other hand; and (v) to measure the impact of COVID infection and of the reduction on the residual plasma concentrations of psychotropic medications (especially antipsychotics and lithium).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients hospitalized in the PROTECTION COVID-19 PSY unit from the Nantes University Hospital may be included, without maximum age limit.
  • Minors, pregnant or nursing women, and patients under guardianship and tutorship may be included, taking into account the study population and the low risks and constraints of the study (observatory)

排除标准

  • minors under 15 years;
  • safeguard of justice;
  • inability to consent (non-opposition);
  • not mastering the reading and writing of the French language well enough.

结局指标

主要结局

impact of the COVID-19 pandemic on psychiatric symptomatology

时间窗: through study completion, an average of 2 year

total severity score from the Impact of Event Scale-Revised (IES-R)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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