Attention deficit and hyperactivity disorder in childhood
Conditions
Interventions
Trade Name: Sedariston Konzentrat
Product Name: Sedariston Concentrate
Pharmaceutical Form: Capsule*
CAS Number: 8001000713
Other descriptive name: HYPERICUM PERFORATUM EXTRACT
Concentration unit: mg
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main efficacy criterion: Treatment difference in score change (day 56 to day 0) in ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) between verum vs. placebo (see Planning of the determination of sample size for the confirmatory analysis in chapter 13.1);Secondary Objective: Secondary efficacy criteria: - Treatment difference in percentage of patients with at least 25% reduction of the ADHDRS-IV-Parent Score (according to atomoxetine study versus placebo, CT Registry ID#2746, Study B4Z-MC-LYAT) - Treatment difference in score difference Montgomery-Åsberg-Depression Rating Scale between day 1 minus day 56 to assess emotional well-being - Treatment difference in Clinical Global Impressions CGI Item 1: Improvement by = 2 categories - Treatment difference in Clinical Global Impressions CGI Item 2: much or very much better - Treatment difference in Clinical Global Impressions CGI Item 3: at least marked improvement - Treatment difference in Continuous Performance Test - Treatment difference in spontaneous movements measured by Doppler radar actometry Safety criteria: - Treatment difference in spontaneous reporting of adverse events - Treatment difference in 17-Item Barkley´s Side Effects Rating Scale ;Primary end point(s): Score change from baseline of the ADHDRS-IV-Parent Version (18-Item-Scale): Investigator Administered and Scored | — |
Countries
Germany
Outcome results
None listed