跳至主要内容
临床试验/EUCTR2005-005012-25-BE
EUCTR2005-005012-25-BE进行中(未招募)不适用

Single blind study to assess the efficacy and tolerance of BF 2.649 in adults suffering from Attention Deficit/Hyperactivity Disorder

BIOPROJET0 个研究点目标入组 20 人开始时间: 2005年11月24日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
BIOPROJET
入组人数
20

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

  • - Male or Female aged from 18 to 65 years old
  • - Ambulatory patients suffering from Attention Deficit / Hyperactivity Disorder (according to DSM-IV criteria)
  • - No specific medications for ADHD treatment
  • - Score superior to 46 on WURS scale
  • - Informed written consent
  • 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
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Psychiatric disorders:
  • - All psychiatric diseases other than ADHD
  • Psychotropic medications:
  • - Any prescription of Atomoxetine, anti-depressants, anti-psychotics, mood stabilizers during the previous 4 weeks,
  • - Any psychostimulants (methylphenidate), benzodiazepine, zolpidem, zopiclone, zaleplon and any medication with psychic effects in the past 2 weeks.
  • - Severe systemic illnesses and any illness, which according to the investigator's judgement, will expose the patient to an excessive risk
  • - ECG: auriculo-ventricular block with PR > 200 MS and/or QTc > 450 ms
  • - Biological tests: values considered to be abnormal by the investigator

研究者

发起方
BIOPROJET

相似试验

Single blind study to assess the efficacy and... | 临床试验