The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •somatic health
- •no previous sex hormone medication
- •willingness to sign the written informed consent
排除标准
- •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
研究组 & 干预措施
hormone treatment for MtF
- cyproterone acetate
- estradiol
- alpha-5-reductase-inhibitor
干预措施: Cyproterone Acetate (Drug)
hormone treatment for MtF
- cyproterone acetate
- estradiol
- alpha-5-reductase-inhibitor
干预措施: Estradiol (Drug)
hormone treatment for MtF
- cyproterone acetate
- estradiol
- alpha-5-reductase-inhibitor
干预措施: 5-alpha reductase inhibitor (Drug)
hormone treatment for FtM
- testosterone undecanoate
- lynestrenol
干预措施: Testolactone undecanoate (Drug)
hormone treatment for FtM
- testosterone undecanoate
- lynestrenol
干预措施: Lynestrenol (Drug)
结局指标
主要结局
change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography
时间窗: 5 months
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
次要结局
未报告次要终点
研究者
Rupert Lanzenberger
A/Prof. PD Dr.
Medical University of Vienna