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
- Conditions
- Attention deficit and hyperactivity disorder in childhood
- Registration Number
- EUCTR2006-005025-31-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
-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
-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
-IQ < 70
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method