Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD
This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
- Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Placebo Control
- Parallel Assignment
|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)|
- ADHD-IV rating scale [ Time Frame: Difference in total score between baseline and end of study ] [ Designated as safety issue: No ]
- Barkley´s Side Effects Rating Scale [ Time Frame: Difference between baseline and each visit ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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.
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
Other Name: Placebo
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.
|Alzey, Germany, 55232|
|DRK Fachklinik für Kinder- und Jugendpsychiatrie|
|Bad Neuenahr, Germany, 53474|
|Berlin, Germany, 13353|
|Praxis für Kinder- und Jugendpsychiatrie|
|Berlin, Germany, 10789|
|Johannes Gutenberg University|
|Mainz, Germany, 55131|
|Principal Investigator:||Michael Huss, Prof. Dr.||Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry|