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临床试验/NCT02409823
NCT02409823已完成不适用

Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

Pontifical Catholic University of Argentina0 个研究点目标入组 665 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
665
主要终点
Occurrence of Adverse Drug Reactions

研究概览

简要总结

Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been found to be effective and safe for the treatment of schizophrenia, bipolar disorders, depressive episodes associated with bipolar disorder, or psychotic symptoms in the context of Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors, at the time that interact with serotoninergic, adrenergic and histaminergic receptors, among others. Quetiapine extended-release has the same clinical efficacy as the immediate-release formulation, but reduces the amount of daily doses, possibly contributing to increased treatment adherence.

The purpose of this registry is to explore adherence to treatment, the occurrence of adverse drug reactions and the clinical outcomes in a sample of patients under treatment with atypical antipsychotics in several Central American countries. For this study, clinical data will be extracted from the medical records of 1000 patients with schizophrenia, depressive disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions, namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic hypotension; adherence to treatment; and changes in quality of life and clinical status will be assessed during the first 8 weeks of 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 18 years-old
  • have a diagnosis of schizophrenia, major depressive disorder, bipolar depressive disorder, parkinson's disease with hallucination
  • such patients should receive antipsychotics as their usual treatment
  • they should give informed consent before participating

排除标准

  • no treatment with atypical antypsichotics
  • other diseases

研究组 & 干预措施

patients on atypical antipsychotics

干预措施: Atypical Antipsychotics (Drug)

结局指标

主要结局

Occurrence of Adverse Drug Reactions

时间窗: 8 weeks

Adherence to treatment

时间窗: 8 weeks

次要结局

  • Quality of Life(8 weeks)
  • Clinical status (CGI score)(8 weeks)

研究者

发起方
Pontifical Catholic University of Argentina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Santiago Perez Lloret

MD PhD CPI

Pontifical Catholic University of Argentina

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