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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00782080
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 13, 2014
Steiner Arzneimittel, Berlin, Germany
Information provided by (Responsible Party):
Prof. Huss, Johannes Gutenberg University Mainz

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

Condition or disease Intervention/treatment Phase
ADHD Drug: Sedariston Drug: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Start Date : July 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Sedariston
St. John´s Wort (100 mg) Valerian Extract (50 mg)
Other Name: Sedariston Concentrate(R)

Placebo Comparator: Placebo campsule
Placebo provided by the company given orally in capsules (size 1 )twice daily
Drug: Placebo

Primary Outcome Measures :
  1. ADHD-IV rating scale [ Time Frame: Difference in total score between baseline and end of study ]

Secondary Outcome Measures :
  1. Barkley´s Side Effects Rating Scale [ Time Frame: Difference between baseline and each visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00782080

Alzey, Germany, 55232
DRK Fachklinik für Kinder- und Jugendpsychiatrie
Bad Neuenahr, Germany, 53474
Praxis für Kinder- und Jugendpsychiatrie
Berlin, Germany, 10789
Charité University
Berlin, Germany, 13353
Johannes Gutenberg University
Mainz, Germany, 55131
Sponsors and Collaborators
Prof. Huss
Steiner Arzneimittel, Berlin, Germany
Principal Investigator: Michael Huss, Prof. Dr. Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry

Responsible Party: Prof. Huss, Prof. Dr. med. Dipl.-Psych. Michael Huss, Johannes Gutenberg University Mainz Identifier: NCT00782080     History of Changes
Other Study ID Numbers: Stei-Sed-0106
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by Prof. Huss, Johannes Gutenberg University Mainz:
St. John`s Wort
Valerian extract

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders