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临床试验/EUCTR2015-000502-19-AT
EUCTR2015-000502-19-AT进行中(未招募)1 期

Effects of sex steroid hormones on serotonin synthesis and degradation measured with PET - Effects of sex hormones on the serotonin system

Medical University of Vienna, Department of Psychiatry and Psychotherapy0 个研究点目标入组 92 人开始时间: 2016年5月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
92

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

  • DSM-5 diagnosis of Gender Dysphoria (DSM-5: 302.85; ICD-10: F64.1)
  • Somatic health based on history, physical examination, ECG, laboratory screening, SCID
  • willingness and competence to sign the informed consent form
  • 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 92
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • concomitant major medical or neurological illness
  • internal or neurologic medical histories as well as pregnancy (positive urine pregnancy test) or breastfeeding
  • other DSM-5 Axis-I comorbidities, determined by a structured clinical interview (SCID), especially body dysmorphic disorder (DSM-5: 300.7; ICD-10: F45.22), schizophrenia spectrum and other psychotic disorders.
  • steroid hormone treatment within 6 months prior to inclusion.
  • treatment with psychotropic agents such as SSRIs
  • any implant or stainless steel graft which poses contraindication for MRI
  • clinically relevant abnormal values in routine laboratory screening or general physical examination
  • current substance abuse or current or past substance related disorder
  • for participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 30 mSv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (Allg. Strahlenschutzverordnung 2010; www.ris.bka.gv.at).
  • failure to comply with the study protocol or to follow the instructions of the investigating team

研究者

发起方
Medical University of Vienna, Department of Psychiatry and Psychotherapy

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