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.
Background:
Sex hormones such as estradiol and testosterone modulate human brain structure and function
and are tightly connected to neuropsychiatric disorders such as depression and anxiety
disorders. Using molecular imaging in humans in vivo, the investigators showed strong
influences of sex hormones on serotonergic neurotransmission via modulation of serotonergic
receptors and transporters. Although, animal studies also indicate strong modulatory
influences on serotonin synthesis and degradation, human data on this potential effect are
absent.
Objectives of the study:
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.
Study design:
Single-blind, longitudinal study. Transsexuals will undergo four PET and two magnetic
resonance imaging (MRI) measurements: 1. One [11C]AMT PET, one [11C]harmine PET and one MRI
measurement before start of treatment, 2. One [11C]AMT PET, one [11C]harmine PET and one MRI
measurement after 4 months of treatment. The investigators propose an overall study duration
of 36 months.
Materials and Methods:
PET measurements will be performed on a GE Advance PET scanner. To examine the
interdependence between serotonin activity and brain structure and function, four MRI
sequences will be performed in order to assess gray matter volume and cortical thickness,
gray and white matter microstructure, as well as resting state functional connectivity and
cerebral blood flow. MRI measurements will be done on a 3 Tesla scanner with high spatial and
temporal resolution.
Study population:
20 healthy female-to-male (FtM), 20 healthy male-to-female (MtF) transsexuals (aged 18-50)
who are free of hormone-medication at baseline; 40 healthy controls, matched for sex, age and
education level.
Pilot Study:
A pilot study without pharmacologic intervention consisting of one optional [11C]AMT PET and
two [11C]harmine PET will be performed in 12 healthy controls in order to optimise PET
measurement procedures.
Relevance and implications of the study:
This will be the first imaging study to investigate the effects of high-dose, long-term
opposite-sex steroid hormones on serotonin synthesis and degradation in the living human
brain using PET. The study will lead to the establishment of a comprehensive theory of
serotonergic modulation by sex steroids and will increase knowledge on the serotonergic role
in shaping brain morphology, microstructure and structural/functional connectivity. Results
will provide essential data for a better understanding of neural sex differences associated
with differences in hormonal states in humans and will elucidate neurobiological correlates
of the known gender difference in the prevalence of neuropsychiatric disorders, thus
contributing to the development of personalized treatment, the reduction of personal
suffering and the reduction of costs and occupational disability.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06098781 -
Gynaecological Gender-affirming Surgeries
|
||
Recruiting |
NCT04064671 -
ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery
|
||
Completed |
NCT03602222 -
An LGBT-Competency Program for Mental Health Professionals in Romania
|
N/A | |
Completed |
NCT04708600 -
Effectiveness of Speech Therapy in Trans Women.
|
N/A | |
Completed |
NCT04195659 -
Chest Dysphoria in Transmasculine Spectrum Adolescents
|
||
Not yet recruiting |
NCT05903911 -
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
|
N/A | |
Not yet recruiting |
NCT04160364 -
Gender Dysphoria in Children and Adolescents : Parents' Perspectives
|
||
Not yet recruiting |
NCT04265885 -
Gender Dysphoria and Transition
|
||
Recruiting |
NCT06245681 -
Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content
|
||
Active, not recruiting |
NCT05489159 -
Sleep and IR in Transgender Adolescents
|
||
Recruiting |
NCT04736797 -
Transition in Transgender
|
||
Recruiting |
NCT04979338 -
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
|
Phase 3 | |
Recruiting |
NCT05829928 -
Testicular Tissue Cryopreservation in the Setting of Gender-Affirming Therapy
|
||
Recruiting |
NCT04993469 -
Patient Reported Outcome on Genital Sensitivity and Sexual Function After Genital Gender Affirming Surgery
|
N/A | |
Recruiting |
NCT05884307 -
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
|
N/A | |
Recruiting |
NCT05883553 -
Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.
|
N/A | |
Completed |
NCT04290286 -
i2TransHealth: Interdisciplinary, Internet-based Trans Health Care
|
N/A | |
Terminated |
NCT03078829 -
The Relation of GnRH Treatment to QTc Interval in Transgender Females
|
||
Recruiting |
NCT05649605 -
Early Mental Response - The EMRE Study
|
N/A | |
Recruiting |
NCT05204732 -
Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People
|
N/A |