EUCTR2013-000970-31-DE进行中（未招募）1 期
Randomized, placebo-controlled multicenter trial of lithium plus treatment asusual (TAU) for acute suicidal ideation and behaviour in patients with suicidalmajor depressive episode - Lithium
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 254
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
- •Diagnosis of a major depressive episode; inpatient at screening visit; suicidal
- •ideation/behaviour present defined by a clinical rating of = 8 on the Sheehan
- •Suicidality Tracking Scale (S-STS) at screening visit and a rating of =20 on the Montgomery
- •Asberg Depression Scale (MADRS) at both screening and baseline visits; both
- •gender, age = 18 years.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •Contraindication for and history of lithium treatment within the past 6 months;
- •patient unable to tolerate lithium treatment in the past; comorbid
- •borderline/antisocial personality disorder, currently active substance
- •dependency; patients with acute or unstable severe medical conditions, patients
- •unable to understand the informed consent or involuntary inpatients, drug dependence (according to ICD10 or DSMIV and positive Diagnose in MINI), pregnancy and lactation
研究者
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