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临床试验/EUCTR2015-003042-47-FR
EUCTR2015-003042-47-FR进行中(未招募)1 期

Psycho-biological substrates of therapeutic benefit of thermal cure on Generalized Anxiety Disorders - Insula-TOP

Centre Hospitalier Henri Laborit0 个研究点开始时间: 2016年2月26日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Diagnostic of TAG according to DSM IV
  • No treatment by antidepressant for at least 2 months
  • No treatment by anxiolytic/neuroleptic/bete blockers/antipsychotic for at least 3 weeks
  • Global score of HAMA is greater or equal to 20
  • Score of HAMA symptoms greater or equal to 8
  • Score of HAMD lower or equal to 7
  • Age: Participants will be males and females, 18-75 years of age included.
  • For women, no ongoing pregnancy/ negative pregnancy test
  • No wounds
  • Affiliation to a social security system (recipient or assignee)
  • Signed written inform consent form
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • Treatment by antidepressant for at least 2 months or a treatment by anxiolytic, neuroleptic for at least 3 weeks
  • Psychotropic treatment (antidepressant, anxiolytic and neuroleptic) between the preinclusion and inclusion
  • Psychotherapy during the 3 months prior to the inclusion
  • Thermal cure during the 6 months prior to the inclusion
  • Treatment by paroxetine (Deroxat® ou Divarius®) for at least 1 month with dose equal or superior to 20 mg per day during the 12 months prior to the inclusion
  • Contraindication to paroxetine
  • Enhanced protection (minors, pregnancies women, nursing women, , people Deprived of liberty by administrative or judicial decision, ...)
  • Blood donation during the 3 months prior to the inclusion

研究者

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