EUCTR2011-003313-42-ES进行中（未招募）不适用
Efficacy of agomelatine on sleep disturbance in Autism Spectrum Disorder (ASD)
Hospital General Universitario de Alicante0 个研究点开始时间: 2011年11月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients must meet all the following criteria:
- •1.Adults patients between 18 and 65 years old, of both sexes.
- •2.Patients diagnosed according ICD-10 criteria for ASD.
- •3.Patients with sleep handicaps (diagnosed according to ICSD-2), after a month to implement sleep hygiene measures.
- •From the Center
- •4.Infanta Leonor of Alicante Patients(outpatient and internal).
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with one or more of the following criteria are NOT eligible to participate in the study:
- •1.Patients who suffer from: epilepsy, physical disability,
- •2.Patients treated with psychotropic drugs, treatment with inhibitors of CYP1A2
- •3.Patients with adverse liver function: transaminases = 1.5 times the normal value.
- •4.Patients with lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
- •5.Patients suffering intercurrent infections or uncontrolled or severe.
- •6.Patients undergoing major surgical procedures, biopsies, or those who have had significant traumatic injury 1 month before the study, or scheduled for major surgery.
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