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
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
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