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

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: Placebo; Drug: Sedariston

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
• Enrollment (Actual): 155
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Alzey, Germany, 55232
    • Rheinhessenfachklinik
  • Bad Neuenahr, Germany, 53474
    • DRK Fachklinik für Kinder- und Jugendpsychiatrie
  • Berlin, Germany, 10789
    • Praxis für Kinder- und Jugendpsychiatrie
  • Berlin, Germany, 13353
    • Charite university
  • Mainz, Germany, 55131
    • Johannes Gutenberg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Sedariston Concentrate(R)
Placebo Comparator: Placebo campsule; Placebo provided by the company given orally in capsules (size 1 )twice daily	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ADHD-IV rating scale	Difference in total score between baseline and end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Barkley´s Side Effects Rating Scale	Difference between baseline and each visit

Collaborators and Investigators

• Sponsor: Prof. Huss
• Collaborators: Steiner Arzneimittel, Berlin, Germany
• Investigators: Principal Investigator: Michael Huss, Prof. Dr., Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 29, 2008
• First Submitted That Met QC Criteria: October 29, 2008
• First Posted (Estimate): October 31, 2008

Study Record Updates

• Last Update Posted (Estimate): March 13, 2014
• Last Update Submitted That Met QC Criteria: March 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Efficacy; ADHD; children; adolescents; St. John's Wort; Valerian extract
• Other Study ID Numbers: Stei-Sed-0106