Observational Study on the Short- and Long-term Effects of Cross-sex-hormone Treatment on Metabolism and Psychopathology in Transsexuals Patients.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transsexualism
- Sponsor
- Max-Planck-Institute of Psychiatry
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)