Clinical Registry of Patients Under Treatment With Atypical Antipsychotics
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
- 否
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
Santiago Perez Lloret
MD PhD CPI
Pontifical Catholic University of Argentina
