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临床试验/EUCTR2011-004860-31-AT
EUCTR2011-004860-31-AT进行中(未招募)1 期

Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders - MAN-BIOPSY

Medical University of Vienna0 个研究点目标入组 0 人开始时间: 2011年10月14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)

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

  • Inclusion criteria for patients:
  • Inclusion criteria for patients are (i) a DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) by a structured clinical interview (SCID); (ii) aged 18 to 50 years; (iii) drug-free within the last three months prior inclusion; (iv) willingness and competence to sign the informed consent form.
  • Inclusion criteria for remitted subjects:
  • Inclusion criteria for remitted subjects are (i) a previous DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) but no symptoms at present, determined by SCID; (ii) aged 18-50 years; (iii) drug-free within the last three months prior inclusion; (iv) willingness and competence to sign the informed consent form.
  • Inclusion criteria for healthy control subjects:
  • Inclusion criteria for healthy control subjects are (i) willingness and competence to sign the informed consent form; (ii) aged 18-50 years; (iii) drug-free
  • 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 300
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusion and removal criteria for study participants:
  • Exclusion criteria for study participants are (i) concomitant major internal or neurological illness; (ii) concomitant psychiatric disorders (except depression and anxiety for patients, excluding PTSD, claustrophobia and bipolar disorder); (iii) ingestion of any antipsychotic, antidepressant, or anti-anxiety agent within the last three months prior to the screening visit; (iv) current substance abuse; (v) failure to comply with the study protocol or to follow the instructions of the investigating team. The appearance of transient side effects of the study medication, such as nausea, agitation or gastrointestinal conditions will not cause removal of subjects in the first place. Patients experiencing continuing side effects from medication such as sexual dysfunction will be subjected to a change of medication to mirtazapine. This will cause the removal from further study participation.

研究者

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