2023-506370-13-00招募中2 期
Involvement of the serotonergic system in the control of impulsivity in Tourette disorder : ARITEP
Hospices Civils De Lyon, Hospices Civils De Lyon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Correlation coefficients between changes in the binding potential (BPND) of [18F]-altanserin measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.
研究概览
简要总结
To determine the correlative links between the availability of serotonergic 5-HT2A receptors and the variations in impulsivity measured in adults with Tourette's syndrome during treatment begin in the routine care.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Administration of a PET radiotracer
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years(18-64 Years, 65+ Years)
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Diagnosed with a Tourette Disorder following the DSM-5
- •Age between 18-65 years
- •Member of a social security scheme in France
- •Freely-given informed consent to participate to this study (written form)
- •With a current treatment by aripiprazole already scheduled
- •With Tics compatible with TEP/fMRI exams
- •Having (for women only) effective contraception throughout participation in the study.
排除标准
- •Male or Female
- •A serious not controlled psychiatric comorbidity
- •A serious, evolving or debilitating pathology with a potential influence on the study
- •Drug-taking with serotonergic effects (e.g., amphetamine, cocaine, MDMA, SSRIs, mianserin)
- •Contraindication for fMRI and PET (e.g., pacemaker, ferromagnetic implant, claustrophobia)
- •Women breastfeeding
- •Protected or restricted person (administratively or in judicial terms)
- •Participants to another study with radiations or radiotracers since less of one year, participants to a concomitant study
- •Do not speak french
结局指标
主要结局
Correlation coefficients between changes in the binding potential (BPND) of [18F]-altanserin measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.
Correlation coefficients between changes in the binding potential (BPND) of [18F]-altanserin measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.
次要结局
- Correlation coefficients between changes in the binding potential (BPND) of [18F]-altanserin measured voxel-by-voxel in the whole brain and the evolution of other clinical scores and task performance of TD patients.
- Correlation coefficients between changes in the BOLD signal measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.
- Correlation coefficients between changes in the BOLD signal measured voxel-by-voxel in the whole brain and the evolution of other clinical scores and task performance of TD patients.
研究者
Pr THOBOIS Stéphane
Scientific
Hospices Civils De Lyon
研究点 (1)
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