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临床试验/EUCTR2012-000778-46-DE
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

Forschungszentrum Jülich GmbH0 个研究点开始时间: 2012年7月18日最近更新:
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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