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临床试验/NCT02185274
NCT02185274已完成不适用

Observational Study on the Short- and Long-term Effects of Cross-sex-hormone Treatment on Metabolism and Psychopathology in Transsexuals Patients.

Max-Planck-Institute of Psychiatry3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
3
主要终点
Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment

研究概览

简要总结

Gender identity disorders (also known as transsexualism) is defined as a condition in which a person with apparently normal somatic sexual differentiation is convinced that he or she is actually a member of the other sex. Most patients therefore undergo so called cross-sex hormone treatment. Treatment protocols follow international consensus statements but vary considerably between different centres and countries since no prospective and controlled trials are available on this subject and recommendations are mainly based on retrospective data analysis and experience of the individual centres. Applying high doses of testosterone to biological females and vice versa high doses of estradiol to biological males definitely impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. Especially in male-to-female-transsexuals there seems to be an increased risk for the development of mood disorders and cardiometabolic comorbidities. In this multi-center observational study we want to investigate, if there is any difference with regard to these outcomes, according to the varying standards of cross-sex hormone treatment between the different centers. Different outcome measures described below will be assessed each time during routine visits at the different centers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment

时间窗: Up to 5 years

Incidence of depressive and anxious symptoms by means of clinical interview and questionnaires in the the study period defined by different cut-off points in the point scales of the corresponding questionnaire (Beck Depression Inventory II = BDII and Symptomcheckliste bei psychischen Störungen = SCL90 for depression and State and Trait Anxiety Inventory = STAI-X1, X2 for anxiety). A comparison will then be done between the different treatment modes.

Differences in the effects of the different treatment types on cardiometabolic parameters

时间窗: Up to 5 years

Differences in the effects of the different treatment types (differing in dose, application route and type of antiandrogen used) on cardiometabolic risk-parameters such as BMI, body-composition, fasting Insulin, fasting glucose, triglycerides, cholesterol, intima media thickness.

次要结局

  • Effects of cross-sex hormone treatment on cortisol secretion by hair cortisol measurements(Up to 5 years)
  • Effects of cross-sex hormone treatment on stress-response by means of Dex/CRH-testing(Up to 5 years)
  • Genetic predictors for treatment response(Up to 5 years)
  • Effects of cross-sex hormone treatment on the metabolome(Up to 5 years)
  • Effects of cross-sex hormone treatment on peripheral neurotrophins(Up to 5 years)
  • Association of hair cortisol and cortisol response during dex/crh-testing with psychopathology-scores assessed by clinical interview and questionnaires(Up to 5 years)
  • Predictive value of hair cortisol and cortisol response in dex/crh-testing treatment for depression and anxiety(Up to 5 years)

研究者

发起方
Max-Planck-Institute of Psychiatry
申办方类型
Other
责任方
Sponsor

研究点 (3)

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