Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 5
- 主要终点
- ADHD-IV rating scale
研究概览
简要总结
This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
Study Design:
- Randomized
- Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Placebo Control
- Parallel Assignment
详细描述
ADHD is a common childhood disorder associated with attention problems and disruptive behavior. Clinical evidence suggests that a herbal drug combination of St. John´s Wort /Valerian extract may be effective in treating ADHD symptoms in methylphenidate and atomoxetine naive patients. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
Participants will be randomly assigned to receive either an herbal product or placebo twice a day for the duration of 8 weeks. Participants will come in for study visits after 2 and 8 weeks for the assessment of ADHD symptoms, performance and spontaneous movements. Side effects will be monitored continuously and also assessed by rating scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV Diagnosis of ADHD
- •Score of ADHDRS-IV-Parent Version ≥24
- •Sufficient knowledge of the German language
- •Written Informed Consent by parents and patients
- •Ability to swallow study medication
- •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. condoms) are necessary, i.e. double-barrier
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 the 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, Nortriptyline
- •Midazolam, Theophylline 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
- •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
研究组 & 干预措施
Sedariston
Sedariston (100 mg St. John´s Wort and 50 mg Valerian extract) capsule given orally in capsules (size 1) twice daily for eight weeks in children (6-11): 1 - 0 -1 In Adolescents (12-17 years) two capsules (size 1) twice daily: 2 - 0 - 2.
干预措施: Sedariston (Drug)
Placebo campsule
Placebo provided by the company given orally in capsules (size 1 )twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
ADHD-IV rating scale
时间窗: Difference in total score between baseline and end of study
次要结局
- Barkley´s Side Effects Rating Scale(Difference between baseline and each visit)
研究者
Prof. Huss
Prof. Dr. med. Dipl.-Psych. Michael Huss
Johannes Gutenberg University Mainz