EUCTR2005-005012-25-FR进行中（未招募）1 期
Etude en simple aveugle évaluant l'efficacité et la tolérance du BF 2.649 dans le trouble de l'attention/hyperactivité de l'adulte
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BIOPROJET
- 入组人数
- 35
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 and 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) 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
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