EUCTR2016-002326-36-DK进行中(未招募)1 期
Effects of erythropoietin (EPO) on cognitive side-effects of electroconvulsive therapy (ECT) (EPO-T)
Region Hovedstadens psykiatriske hospital0 个研究点目标入组 52 人开始时间: 2016年6月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •We will recruit patients with unipolar or bipolar depression who are
- •scheduled for ECT treatment at Psychiatric Centre Copenhagen and
- •Psychiatric Centre Frederiksberg (and other centers in the Capitol Region
- •if necessary). Patients will be screened with Mini Mental Neuropsychiatric Interview (M.I.N.I.) to confirm ICD-10 diagnosis.
- •Eligible patients are between 18-70 years old and have a diagnosis of
- •major depression (MDD) unipolar or bipolar (BD) with current moderate
- •to severe depressive symptoms. They should have a Hamilton
- •Depression Rating Scale 17-items (HDRS-17) score =17, have Danish as
- •their native language and be able to give informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Exclusion criteria are: treatment under involuntary measures, previous ECT within the last three months, other neuropsychiatric conditions,
- •alcohol or substance misuse disorder. To ensure safety of EPO treatment, patients are also excluded if they have a significant medical
- •condition (incl. diabetes, renal failure, epilepsy, hypertension,
- •malignancies or thromboses), pregnancy, contraceptive
- •medication or a family history of thromboses or seizures.
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