EUCTR2011-005001-78-AT进行中（未招募）1 期
eural Correlates of SSRI Drug Response: Impact of Stress System Genes - not available
Medizinische Universität Wien, Universitätsklinik für Psychiatrie u. Psychotherapie, Abteil. für biologische Psychiatrie0 个研究点目标入组 0 人开始时间: 2012年1月3日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •- willingness and competence to sign the informed consent form voluntarily
- •- aged 18 – 45 years
- •- right-handedness
- •- a DSM-IV diagnosis of a major depressive episode by a structured clinical interview (SCID)
- •- a MADRS score =20 and = 30
- •- ability to be managed as outpatients
- •- ability to fulfill the criteria to undergo an MRI scan
- •- Caucasian subjects of European ancestry
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- previous or concurrent major medical or neurological illness
- •- clinically significant abnormal values in routine laboratory screening or general physical examination
- •- DSM-IV diagnosis of substance dependence within the past year, except for caffeine or nicotine or current substance abuse
- •- DSM-IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or an anxiety disorder as a primary diagnosis
- •- the use of any psychotropic drug within the last two months
- •- unresponsiveness of a former major depressive episode to an adequate antidepressive drug dosing of at least 6 weeks duration or any kind of therapy resistance
- •- a history of severe drug allergy or hypersensitivity or known hypersensitivity to escitalopram
- •- being acutely suicidal either indicated by a score = 5 on item 10 (suicidal thoughts) on the MADRS or a score = 4 on the HAM-D 21 (suicidal thoughts) or according to the investigator´s opinion
- •- failures to comply with the study protocol or to follow the instructions of the investigating team
- •- current pregnancy or breast feeding;
- •- metallic implants or other contraindications to MRI
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