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临床试验/NCT01487291
NCT01487291已完成不适用

Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Psychotic Patients

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Prevalence of hypofibrinolysis markers in psychotic patients

研究概览

简要总结

At the Thrombophilia Clinic of the Hospital Federal dos Servidores do Estado do Rio de Janeiro there is a high prevalence of acute psychotic episodes, which allows the investigators to raise the suspicion that the thrombotic tendency or hypofibrinolysis play a role in the onset of the disease. It is striking that most of these patients, after some time on anticoagulants, no longer need to take psychiatric medication.

详细描述

If the thrombotic tendency plays a significant role in the etiology of psychosis, one would expect to find ischemic brain injuries in neuroimaging studies, but it does not happen. Therefore, if there is a correlation between thrombotic tendency-hypofibrinolysis and psychosis it is likely to occur at the biochemical level, such as in neuronal transmission.

The investigators hypothesis is that mechanisms that inhibit tissue plasminogen activator (t-PA) and therefore promote hypofibrinolysis, are directly or indirectly involved in the genesis of psychosis, because t-PA participates in neuronal plasticity and low t-PA levels are related to dementia.

Hypofibrinolysis due to t-PA inhibition can be seen in:

  • Insulin resistance, when the pancreas must produce large amounts of insulin and proinsulin by feedback. If pancreatic reserve is inadequate, the result is diabetes mellitus. If the response is adequate, proinsulin stimulates the production of PAI-1 (plasminogen activator inhibitor 1. PAI-1 inhibits the formation of plasmin, whose function is to dissolve fibrin which makes up the clot. Obesity, certain infections and inflammations potentiate insulin resistance.
  • Antiphospholipid antibody syndrome.
  • PAI-1 4G/5G or 4G/4G polymorphism.

Some hypofibrinolysis indicators are:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of schizophrenia or schizoaffective disorder by the Semi-structured Interview MINI 5.0.

排除标准

  • Inability to provide information.
  • Use of illicit drugs.
  • Infections such as cerebral toxoplasmosis in HIV seropositive or tertiary syphilis. Patients with "recurrent syphilis" will not be excluded, because false positive tests are common in antiphospholipid antibody syndrome.

结局指标

主要结局

Prevalence of hypofibrinolysis markers in psychotic patients

时间窗: One year

The investigators' hypothesis is that a high prevalence of hypofibrinolysis markers will be probably found in psychotic patients.

次要结局

  • Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Patients who Need Electroconvulsive Therapy(2013-2014)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Hoirisch Clapauch

MD, Responsible for the HFSE Thrombophilia Clinic

Universidade Federal do Rio de Janeiro

研究点 (1)

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