Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Huss
• Collaborator: Steiner Arzneimittel, Berlin, Germany

Criteria

Inclusion Criteria:

• 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

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 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

• 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

• 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