跳至主要内容
临床试验/2023-506370-13-00
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

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

发起方
Hospices Civils De Lyon, Hospices Civils De Lyon
申办方类型
Hospital/Clinic/Other health care facility, Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Pr THOBOIS Stéphane

Scientific

Hospices Civils De Lyon

研究点 (1)

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