Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Johannes Gutenberg University Mainz.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Johannes Gutenberg University Mainz
Collaborator:
Steiner Arzneimittel, Berlin, Germany
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00782080
First received: October 29, 2008
Last updated: August 3, 2009
Last verified: August 2009
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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 St. John`s Wort Valerian Extract Efficacy Safety. |
Drug: St. John´s Wort/Valerian Extract 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 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
St. John´s Wort/Valerian extract given orally in capsules (size 1)twice daily
|
Drug: St. John´s Wort/Valerian Extract
St. John´s Wort (100 mg) Valerian Extract (50 mg)
Other Name: Sedariston Concentrate(R)
|
|
Placebo Comparator: B
Placebo 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782080
Contacts
| Contact: Michael Huss, Prof. Dr. | 0049-6131-17- ext 3281 | michael.huss@ukmainz.de |
Locations
| Germany | |
| Rheinhessenfachklinik | Recruiting |
| Alzey, Germany, 55232 | |
| Contact: Cornelia Dehm 0049-6731-50- ext 1609 C.DEHM@Rheinhessen-Fachklinik-Alzey.de | |
| Principal Investigator: Cornelia Dehm | |
| DRK Fachklinik für Kinder- und Jugendpsychiatrie | Recruiting |
| Bad Neuenahr, Germany, 53474 | |
| Contact: Kristian Holtkamp, PD Dr. med. 02641-7540 | |
| Principal Investigator: Kristian Holtkamp, PD Dr. med. | |
| Charité University | Recruiting |
| Berlin, Germany, 13353 | |
| Contact: Lehmkuhl Ulrike, Prof. Dr. Ulrike.Lehmkuhl@charite.de | |
| Sub-Investigator: Dominik Schmidt | |
| Praxis für Kinder- und Jugendpsychiatrie | Recruiting |
| Berlin, Germany, 10789 | |
| Contact: Peter Greven, Dr. med. 030-21016531 | |
| Principal Investigator: Peter Greven, Dr. med. | |
| 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. | |
Sponsors and Collaborators
Johannes Gutenberg University Mainz
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: | Michael Huss/ Prof. Dr. med. Dipl.-Psych., Johannes Gutenberg University Mainz, Dep. of Child and Adolescent Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00782080 History of Changes |
| Other Study ID Numbers: | Stei-Sed-0106 |
| Study First Received: | October 29, 2008 |
| Last Updated: | August 3, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Hyperkinesis Attention Deficit Disorder with Hyperactivity Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013