EUCTR2006-005025-31-DE进行中（未招募）不适用
Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) versus Placebo in Children and Adolescents with Attention Deficit/Hyperactivity Disorder (ADHD) - SED-ADHS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •-Written Informed Consent by parents and patients (separately for age groups 6 – 11 years and 12 – 17 years)
- •-Children and adolescents of both sexes in the age group between 6 and 17 years
- •-Confirmed diagnosis of ADHD by semi-structured clinical interview K-SADS verified (score ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored =24)
- •-Acceptance and Capability to swallow capsules of size 1
- •-Sufficient knowledge of the German language
- •-Sexually mature and active adolescents with highly effective methods of birth control: contraception according to Pearl-Index<1; when use of oral contraceptives, additional methods of contraception (e.g. condomes) are necessary, i.e. double-barrier
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Known hypersensitivity against St. John´s wort or Valerian root or one of the excipients
- •-Known hypersensitivity of the skin when exposed to sunlight
- •-All serious internal diseases, and for this reason:
- •-Current intake of following medication: Ciclosporin, Tacrolimus, Indinavir and other protease inhibitors in the anti-HIV treatment, Irinotecan and other cytostatics, anticoagulants of the Cumarin-type, Digoxin, Amitriptylin, Nortriptylin, Midazolam, Theophyllin or other medication with photosensitive effects
- •-All severe psychiatric diseases except oppositional defiant disorders (according to items 21-28 SNAP-IV) and conduct disorders (according to items 41-45 SNAP-IV), and for this reason:
- •-Current intake of the following medication: antidepressants and other psychotropic medication
- •-Indication for hospitalization
- •-Suicidality (including suicidal thoughts): Score =3 in item 10 of MADRS
- •-Pregnancy, lactation
- •-Positive screening for metabolites of illegal drugs in urine
- •-Previous medication with stimulants and/or atomoxetine
- •-Psychotropic co-medication
- •-Placement in an institution on official or judicial ruling
- •-Lack of willingness to store and transmit pseudonym data according to German regulations
- •-Parallel participation in another clinical trial according to German Drug Law (AMG), or less than 4 weeks ago
- •-Patients requiring a primary medication with methylphenidate during the study period of 8 weeks
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