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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
155
St. John´s Wort (100 mg) Valerian Extract (50 mg)
Placebo
Rheinhessenfachklinik
Alzey, Germany
DRK Fachklinik für Kinder- und Jugendpsychiatrie
Bad Neuenahr, Germany
Praxis für Kinder- und Jugendpsychiatrie
Berlin, Germany
Charité University
Berlin, Germany
ADHD-IV rating scale
Time frame: Difference in total score between baseline and end of study
Barkley´s Side Effects Rating Scale
Time frame: Difference between baseline and each visit
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Johannes Gutenberg University
Mainz, Germany