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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
  Purpose

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 Intervention Phase
ADHD
Drug: Sedariston
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • ADHD-IV rating scale [ Time Frame: Difference in total score between baseline and end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Barkley´s Side Effects Rating Scale [ Time Frame: Difference between baseline and each visit ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782080

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

No publications provided

Responsible Party: Prof. Huss, Prof. Dr. med. Dipl.-Psych. Michael Huss, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT00782080     History of Changes
Other Study ID Numbers: Stei-Sed-0106
Study First Received: October 29, 2008
Last Updated: March 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
ADHD
children
adolescents
St. John`s Wort
Valerian extract
Safety
Efficacy

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on November 25, 2014