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临床试验/NCT06011460
NCT06011460Enrolling By Invitation不适用

Observation of Clozapine Treatment Safety in Bipolar Disorder.

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
Safety measures of clozapine treatment in patients with bipolar disorder.

研究概览

简要总结

The purpose of the registry is to record incidence of adverse events during treatment with clozapine in patients suffering from bipolar disorder.

详细描述

Bipolar disorder, with its spectrum, remains a life-long and significant mental health concern due to its unpredictable nature and varied symptomatology. Despite the wide array of available treatments, some cases of bipolar disorder remain resistant to traditional medications. Clozapine, traditionally used for treatment-resistant schizophrenia, has shown promising results in managing resistant cases of bipolar disorder, particularly reducing the risk of suicide. There are not enough controlled studies on clozapine, especially in treatment resistant bipolar depression.

There are certain limitations associated with the use of clozapine, primarily related to the possibility of adverse events including agranulocytosis, myocarditis, pneumonia, intestinal obstruction and seizures. Therefore, there is a need for more studies on safety and tolerability of this treatment in patients with bipolar disorder.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to DSM-
  • Age from 18 to 65 years old.

排除标准

  • Patients unable to give fully written informed consent
  • Patients unable to comply with the requirements

研究组 & 干预措施

Patients' name

Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5. Age from 18 to 65 years old.

干预措施: Clozapine (Drug)

结局指标

主要结局

Safety measures of clozapine treatment in patients with bipolar disorder.

时间窗: 1 year

Incidence of possible occurrence of adverse events during treatment with clozapine in patients with bipolar disorder.

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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