Transsexualism Clinical Trial
Official title:
The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography
Verified date | January 2014 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
The aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand [11C]DASB. Specifically, the 5-HTT binding will be quantified before and after hormone therapy underwent by 10 male-to-female (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level, long-term administration of opsite sex steroid hormones in transsexuals provide the unique opportunity to investigate the influence of sex steroid hormones on the serotonergic system. Since the serotonin transporter serves as a primary target molecule for antidepressant treatment, the results of the study will be of benefit for the assessment of the clinical relevance of estrogen and testosterone as modulatory and neuroactive agents.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - somatic health - no previous sex hormone medication - willingness to sign the written informed consent Exclusion Criteria: - severe diseases - steroid hormone treatment within 6 months prior inclusion - treatment with psychotropic agents such as selective serotonin reuptake inhibitors (SSRIs) - any implant or stainless steel graft - positive urine pregnancy test in women at the screening visit at each PET day |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Austria | Department of Psychiatry and Psychotherapy, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography | The serotonin-transporter BP will be assessed in a 90 min. dynamic PET measurement session at three timepoints: before start of hormonal therapy, after four weeks of hormonal therapy, and after 4 months of hormonal therapy | 5 months | No |
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