Effects of Sex Steroid Hormones on Serotonin Synthesis and Degradation Measured With PET
试验速览
- 阶段
- 4 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- blood-to-brain clearance/trapping (K*) of [11C]AMT
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Female-to-Males
Female-to-Male Transsexuals receiving Testosterone treatment
干预措施: Testosterone (Drug)
Female-to-Males
Female-to-Male Transsexuals receiving Testosterone treatment
干预措施: Lynestrenol (Drug)
Female-to-Males
Female-to-Male Transsexuals receiving Testosterone treatment
干预措施: Triptorelin acetate (Drug)
Male-to-Females
Male-to-Female Transsexuals receiving Estradiol and Anti-androgen treatment
干预措施: Cyproterone Acetate (Drug)
Male-to-Females
Male-to-Female Transsexuals receiving Estradiol and Anti-androgen treatment
干预措施: Estradiol (Drug)
Male-to-Females
Male-to-Female Transsexuals receiving Estradiol and Anti-androgen treatment
干预措施: Triptorelin acetate (Drug)
结局指标
主要结局
blood-to-brain clearance/trapping (K*) of [11C]AMT
时间窗: <5 months
\[11C\]AMT trapping as an estimation of brain serotonin synthesis in vivo in humans
distribution volume (DV) of [11C]harmine
时间窗: <5 months
distribution volume of specifically bound radioligand \[11C\]harmine in brain regions
次要结局
- white and gray matter microstructure(<5 months)
- gray matter volume/density and cortical thickness(<5 months)
- cerebral blood flow (CBF)(<5 months)
- Scores on the Klein Sexual Orientation Grid (KSOG)(<5 months)
- Scores on the Utrecht Gender Dysphoria Scale(<5 months)
研究者
Rupert Lanzenberger
Assoc. Prof.
Medical University of Vienna