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临床试验/EUCTR2017-004514-25-ES
EUCTR2017-004514-25-ES进行中(未招募)1 期

EFFICACY AND SAFETY OF THE ADMINISTRATION OF THE PASSIFLORA EXTRACT FOR BENZODIAZEPINE WITHDRAWAL IN INSTITUTIONALIZED OLDER ADULTS : CLINICAL TRIAL PHASE III. - SEDISTRESS

utrición Medica S.L.0 个研究点目标入组 108 人开始时间: 2018年6月20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)
发起方
入组人数
108

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

入选标准

  • 1. Age > 65 years old
  • 2. Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)
  • 3. Capable of giving consent and to answer the questionnaires according to researcher criteria
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 108

排除标准

  • 1. Diagnosis of dementia moderate or severe (Test Minimental = 20).
  • 2. Acute confusional syndrome at the inclusion
  • 3- Panic disorder
  • 4. Obsesive-compulsive disorder
  • 5. Any type of psycosis or bipolar disorder
  • 6. Severe Parkison disease diagnosed
  • 7. Current or past diagnosis of epilepsia
  • 8. Recent stroke (last month)
  • 9. Thyroid disorders not controlled or uncompensated
  • 10. Alteration of deglutition
  • 11. Previous drugs or alcohol abuse
  • 12. Hospitalization (more than 24 hours) during the last month
  • 13. Complex priority treatment (dialisis, chemotherapy...)
  • 14. Life expectation less than 1 year
  • 15. Benzodiazepines therapeutic uses not for anxiety or insomnio

研究者

发起方
utrición Medica S.L.

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