Gender Dysphoria Clinical Trial
Official title:
Effects of Sex Steroid Hormones on Serotonin Synthesis and Degradation Measured With PET
The aim of this study is to prove the modulatory influence of sex hormones on serotonergic neurotransmission by determining the enzymatic processes involved in serotonin synthesis and degradation using positron emission tomography (PET) in humans in vivo with the radiotracers [11C]AMT and [11C]harmine.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - DSM-5 diagnosis of Gender Dysphoria (DSM-5: 302.85; ICD-10: F64.1) (for transsexuals only) - Somatic health based on history, physical examination, ECG, laboratory screening, SCID - willingness and competence to sign the informed consent form Exclusion Criteria: - 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 dysphoric 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 - 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 20 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Psychiatry and Psychotherapy, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Aggarwal M, Puri V, Puri S. Effects of estrogen on the serotonergic system and calcitonin gene-related peptide in trigeminal ganglia of rats. Ann Neurosci. 2012 Oct;19(4):151-7. doi: 10.5214/ans.0972.7531.190403. — View Citation
Hahn A, Kranz GS, Küblböck M, Kaufmann U, Ganger S, Hummer A, Seiger R, Spies M, Winkler D, Kasper S, Windischberger C, Swaab DF, Lanzenberger R. Structural Connectivity Networks of Transgender People. Cereb Cortex. 2015 Oct;25(10):3527-34. doi: 10.1093/cercor/bhu194. Epub 2014 Sep 12. — View Citation
Hahn A, Kranz GS, Sladky R, Kaufmann U, Ganger S, Hummer A, Seiger R, Spies M, Vanicek T, Winkler D, Kasper S, Windischberger C, Swaab DF, Lanzenberger R. Testosterone affects language areas of the adult human brain. Hum Brain Mapp. 2016 May;37(5):1738-48. doi: 10.1002/hbm.23133. Epub 2016 Feb 15. — View Citation
Kranz GS, Hahn A, Kaufmann U, Küblböck M, Hummer A, Ganger S, Seiger R, Winkler D, Swaab DF, Windischberger C, Kasper S, Lanzenberger R. White matter microstructure in transsexuals and controls investigated by diffusion tensor imaging. J Neurosci. 2014 Nov 12;34(46):15466-75. doi: 10.1523/JNEUROSCI.2488-14.2014. — View Citation
Kranz GS, Wadsak W, Kaufmann U, Savli M, Baldinger P, Gryglewski G, Haeusler D, Spies M, Mitterhauser M, Kasper S, Lanzenberger R. High-Dose Testosterone Treatment Increases Serotonin Transporter Binding in Transgender People. Biol Psychiatry. 2015 Oct 15;78(8):525-33. doi: 10.1016/j.biopsych.2014.09.010. Epub 2014 Sep 23. — View Citation
Purves-Tyson TD, Handelsman DJ, Double KL, Owens SJ, Bustamante S, Weickert CS. Testosterone regulation of sex steroid-related mRNAs and dopamine-related mRNAs in adolescent male rat substantia nigra. BMC Neurosci. 2012 Aug 6;13:95. doi: 10.1186/1471-2202-13-95. — View Citation
Smith LJ, Henderson JA, Abell CW, Bethea CL. Effects of ovarian steroids and raloxifene on proteins that synthesize, transport, and degrade serotonin in the raphe region of macaques. Neuropsychopharmacology. 2004 Nov;29(11):2035-45. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood-to-brain clearance/trapping (K*) of [11C]AMT | [11C]AMT trapping as an estimation of brain serotonin synthesis in vivo in humans | <5 months | |
Primary | distribution volume (DV) of [11C]harmine | distribution volume of specifically bound radioligand [11C]harmine in brain regions | <5 months | |
Secondary | white and gray matter microstructure | microstructure measured using diffusion weighted imaging | <5 months | |
Secondary | gray matter volume/density and cortical thickness | structural MRI measurements | <5 months | |
Secondary | cerebral blood flow (CBF) | cerebral blood flow measured using arterial spin labeling MRI | <5 months | |
Secondary | Scores on the Klein Sexual Orientation Grid (KSOG) | the KSOG measures sexual orientation | <5 months | |
Secondary | Scores on the Utrecht Gender Dysphoria Scale | Score for gender dysphoria | <5 months |
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