DRKS00003134尚未招募不适用
Evaluation of striatal dopamine transporter availability in patients with therapyresistent major depression, treated by sleep deprivation and electroconvulsive therapy
niversitätsklinik Freiburg0 个研究点目标入组 24 人开始时间: 2011年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years(—)
- 性别
- All
入选标准
- •a) written informed consent
- •b) age 18 to 80 years
- •c) patients: diagnosis of major depression according to ICD10 criteria AND refractory to at least two preceding evidence-based therapies, scheduled for SD and ECT
- •d) cerebral MRI without structural changes possibly responsible for an affective disorder
排除标准
- •e) pregnancy (excluded by pregnancy test in fertile women) and lactation
- •f) comorbidity of another psychiatric disease (axis I disorder or substance abuse within last 6 months in patients resp. ever in controls)
- •g) intake of drugs or substances inferring with DAT binding (e.g. mazindol, bupropione, radafaxine, amphetamine, methamphetamine, methylphenidate, cocaine, etc.)
- •h) conditions that may preclude proper SPECT acquisition (e.g., severe claustrophobia, back pain, etc.)
- •i) previous participation in nuclear medicine trials
- •j) participation in medical trails within the last 6 months
- •k) symptomatic affective disorder (e.g, due to a structural brain lesion on MRI)
- •l) severe neurological disease, in particular those affecting nigrostriatal integrity (e.g., dementia, neurodegenerative Parkinson syndrome, restless legs syndrome, epilepsy, cerebrovascular disease)
- •m) any malignant disease with possible impact on life expectancy
- •n) severe cardiovascular disease e.g. Angina, chronic heart failure, arrhythmia)
- •o) any severe internal disease with possible impact on life expectancy (e.g., CAD, uncontrolled hypertension, liver or kidney disease, etc.)
- •p) known allergic reaction on perchlorate, relevant thyroid disease (e.g., thyroid cancer; preoperative need to block thyroid with iodine), relevant abnormal blood counts, earlier blood count changes due to perchlorate.
- •q) acute suicidal tendencies
- •r)difficulties to give informend consent
研究者
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