EUCTR2012-000778-46-DE进行中(未招募)不适用
Elucidation of Lithium Working Mechanism in Bipolar Disorder by means of Multi Modal Brain Imaging (LiBiDi) - LiBiDi
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
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
- •For all volunteers:
- •blood examinations (normal level)
- •thyroidal parameters (normal level)
- •ECG (normal level)
- •negative drug screening in urine (Benzodiazepine, Opiate, Amphetamine, Cannabis)
- •no nephrological or thyroidal diseases in the medical history
- •no metal in the human body
- •no retainer
- •Age between 18 and 60 years
- •body weight > 50 kg
- •pregnancy test negative
- •For bipolar patients with Lithium rehabilitation:
- •Diagnosis bipolar disorder type 1 referred to DSM-IVR criteria
- •euthymic condition
- •monotherapy with Lithium
- •Lithium therapy at least for 12 months (familiar preparation, no change to another preparation)
- •For bipolar patients - Lithium naive:
- •Diagnosis bipolar disorder type 1 referred to DSM-IVR criteria
- •euthymic condition
- •no Lithium medication in the past
- •no other medication for the mood treatment
- •For healthy volunteers:
- •no first degree relatives with psychiatric diseases in the past
- •no psychiatric or neurological diseases in the past
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Volunteers and patients, who are not in the suitable condition for the informed consent
- •- pregnancy
- •- volunteers and patients before they have reached the majority age
- •- persons with an exposure dose to 20 mSv during the last year
- •- persons with an exposure dose to 400 mSv during the whole life
- •- bipolar patients with psychiatric comorbidity like dependence, personality disorder or psychotic symptoms
- •- persons, who were in a static magnetic field of 9,4T longer than 24 hours during the last year
- •magnetic metal implants, contraceptive coil, tattoos
研究者
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