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

Phase 3

Completed

• Conditions: ADHD
• Interventions: Drug: Sedariston; Drug: Placebo

• Registration Number: NCT00782080
• Lead Sponsor: Prof. Huss

Brief 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

Detailed Description

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Primary Completion: 2010-03
• Study Completion: 2010-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedariston	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.
Placebo campsule	Placebo	Placebo provided by the company given orally in capsules (size 1 )twice daily

Primary Outcome Measures

Name	Time	Method
ADHD-IV rating scale	Difference in total score between baseline and end of study

Secondary Outcome Measures

Name	Time	Method
Barkley´s Side Effects Rating Scale	Difference between baseline and each visit

Trial Locations

Locations (5)

Rheinhessenfachklinik; 🇩🇪 Alzey, Germany

DRK Fachklinik für Kinder- und Jugendpsychiatrie; 🇩🇪 Bad Neuenahr, Germany

Johannes Gutenberg University; 🇩🇪 Mainz, Germany

Praxis für Kinder- und Jugendpsychiatrie; 🇩🇪 Berlin, Germany

Charité University; 🇩🇪 Berlin, Germany