- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02185274
Observational Study on Metabolism and Psychopathology in Transsexual Patients
Observational Study on the Short- and Long-term Effects of Cross-sex-hormone Treatment on Metabolism and Psychopathology in Transsexuals Patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Erlangen, Germany, 91054
- Gynaecological department of the University hospital of Erlangen
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Hamburg, Germany, 20246
- Institute for Sex Research and Forensic Psychiatry
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Munich, Germany, 80333
- Hormon- und Stoffwechselzentrum München
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria
- Patients with the diagnosis gender identity disorder (ICD-10: F64.0), who have given written informed consent following adequate oral and written information.
General Exclusion criteria
- Patients below the age of 18
- Legally incompetent patients
- Prior intake of cross-sex hormones
- Missing written informed consent
- Intersexuality
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of depressive and anxious symptoms following initiation of cross-sex hormone treatment
Time Frame: Up to 5 years
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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.
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Up to 5 years
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Differences in the effects of the different treatment types on cardiometabolic parameters
Time Frame: Up to 5 years
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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.
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of cross-sex hormone treatment on cortisol secretion by hair cortisol measurements
Time Frame: Up to 5 years
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Assessment of cortisol secretion by a hair sample which provides information about the mean cortisol secretion during the last months.
One cm of scalp hair resembles approximately 1 month of growth.
This may provide additional information concerning overall cortisol secretion during the last 3 months.
One small hair will be sampled by scalp and this will be analysed in regard to psychological and metabolic profiles.
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Up to 5 years
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Effects of cross-sex hormone treatment on stress-response by means of Dex/CRH-testing
Time Frame: Up to 5 years
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The Dex/CRH-Test has been in use for several years for testing the physiological cortisol-response in psychiatric and neurologic patients and is performed on a routine basis in the Max-Planck Institute for Psychiatry in patients suffering from depressive disorders.
It is assumed that regulation of cortisol secretion and responsiveness of the hypothalamus-pituitary-adrenal (HPA)-axis is pathophysiologically related to depression.
The test has been proven to be save.
Common transient side-effects include flushing, palpitation, tachypnoea and feeling of warmth which usually resolve within minutes without further intervention.
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Up to 5 years
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Genetic predictors for treatment response
Time Frame: Up to 5 years
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Predictive value of different polymorphism in genes such as the ERa, ERb and AR (Androgen Receptor), GR (Glucocorticoid-Receptor) or genes involved in steroid metabolism and function on metabolic profiles, breast development and psychiatric outcome.
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Up to 5 years
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Effects of cross-sex hormone treatment on the metabolome
Time Frame: Up to 5 years
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Differences in plasma and urine metabolome in plasma such as amino acids; carbohydrates and related; catecholamines and related; complex lipids and related; energy metabolism and organic acids; fatty acids (free and from lipids); purines, pyrimidines and related; steroids and related; vitamins, cofactors and related.
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Up to 5 years
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Effects of cross-sex hormone treatment on peripheral neurotrophins
Time Frame: Up to 5 years
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Effects of cross-sex hormone treatment on serum Brain-Derived Neurotrophic Factor (BDNF) levels will be assessed in regular intervals during routine visits.
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Up to 5 years
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Association of hair cortisol and cortisol response during dex/crh-testing with psychopathology-scores assessed by clinical interview and questionnaires
Time Frame: Up to 5 years
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The following interviews will be used:
The following questionaires will be used • stress coping (SVF-78) Personality:
Psychopathology:
Associations of cortisol- and ACTH response following dex/crg-challenge will be analyzed with regard to the presence of depression assessed by clinical interview and psychopathology scores assessed by BDI and STAIX. The other questionnaires will be used for multidimensional modelling. |
Up to 5 years
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Predictive value of hair cortisol and cortisol response in dex/crh-testing treatment for depression and anxiety
Time Frame: Up to 5 years
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Predictive value of hair cortisol 3 month at baseline and after treatment initiation and cortisol response at baseline and after 3 month after treatment initiation during dex/crh-testing for 12 month incidence of depressive or anxiety disorders assessed by clinical interview and questionnaires. The following interviews will be used:
The following questionaires will be used
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Up to 5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthias K Auer, MD, Max Planck Insitute of Psychiatry, Department of Neuroendocrinology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MPIP-ENDO1
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