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Sponsors and Collaborators: |
Johannes Gutenberg University Mainz Steiner Arzneimittel, Berlin, Germany |
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Information provided by: | Johannes Gutenberg University Mainz |
ClinicalTrials.gov Identifier: | NCT00782080 |
This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.
Study Design:
Condition | Intervention | Phase |
---|---|---|
ADHD St. John`s Wort Valerian Extract Efficacy Safety. |
Drug: St. John´s Wort/Valerian Extract Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 150 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
St. John´s Wort/Valerian extract given orally in capsules (size 1)twice daily
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Drug: St. John´s Wort/Valerian Extract
St. John´s Wort (100 mg) Valerian Extract (50 mg)
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B: Placebo Comparator
Placebo given orally in capsules (size 1)twice daily
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Drug: Placebo
Placebo
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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.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Sexually mature and active adolescents with highly effective methods of birth control:
Exclusion Criteria:
All serious internal diseases, and for this reason: Current intake of the following medication:
Contact: Michael Huss, Prof. Dr. | 0049-6131-17- ext 3281 | michael.huss@ukmainz.de |
Germany | |
Johannes Gutenberg University | Recruiting |
Mainz, Germany, 55131 | |
Contact: Michael Huss, Prof. Dr. 0049-6131-17- ext 3281 michael.huss@ukmainz.de | |
Sub-Investigator: Birte Behn, Dr. med. | |
Charité University | Recruiting |
Berlin, Germany, 13353 | |
Contact: Lehmkuhl Ulrike, Prof. Dr. Ulrike.Lehmkuhl@charite.de | |
Sub-Investigator: Dominik Schmidt | |
Rheinhessenfachklinik | Recruiting |
Alzey, Germany, 55232 | |
Contact: Cornelia Dehm 0049-6731-50- ext 1609 C.DEHM@Rheinhessen-Fachklinik-Alzey.de | |
Principal Investigator: Cornelia Dehm |
Principal Investigator: | Michael Huss, Prof. Dr. | Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry |
Responsible Party: | Johannes Gutenberg University Mainz, Dep. of Child and Adolescent Psychiatry ( Michael Huss/ Prof. Dr. med. Dipl.-Psych. ) |
Study ID Numbers: | Stei-Sed-0106 |
Study First Received: | October 29, 2008 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00782080 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
ADHD children adolescents St. John`s Wort Valerian extract |
Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Attention Deficit and Disruptive Behavior Disorders Hyperkinesis |