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

This study has been completed.
Sponsor:
Collaborator:
Steiner Arzneimittel, Berlin, Germany
Information provided by (Responsible Party):
Prof. Huss, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00782080
First received: October 29, 2008
Last updated: March 12, 2014
Last verified: March 2014

October 29, 2008
March 12, 2014
July 2008
March 2010   (final data collection date for primary outcome measure)
ADHD-IV rating scale [ Time Frame: Difference in total score between baseline and end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00782080 on ClinicalTrials.gov Archive Site
Barkley´s Side Effects Rating Scale [ Time Frame: Difference between baseline and each visit ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD
Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
ADHD
  • Drug: Sedariston
    St. John´s Wort (100 mg) Valerian Extract (50 mg)
    Other Name: Sedariston Concentrate(R)
  • Drug: Placebo
    Placebo
    Other Name: Placebo
  • Experimental: 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.
    Intervention: Drug: Sedariston
  • Placebo Comparator: Placebo campsule
    Placebo provided by the company given orally in capsules (size 1 )twice daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
June 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00782080
Stei-Sed-0106
Yes
Prof. Huss, Johannes Gutenberg University Mainz
Prof. Huss
Steiner Arzneimittel, Berlin, Germany
Principal Investigator: Michael Huss, Prof. Dr. Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
Johannes Gutenberg University Mainz
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP