Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD) - Full Text View

Sponsors and Collaborators:	Johannes Gutenberg University Mainz Steiner Arzneimittel, Berlin, Germany
Information provided by:	Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:	NCT00782080

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 III

Drug Information available for: Valerian

U.S. FDA Resources

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)

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:	August 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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)
B: Placebo Comparator Placebo given orally in capsules (size 1)twice daily	Drug: Placebo 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
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

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

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

Keywords provided by Johannes Gutenberg University Mainz:

ADHD
children
adolescents
St. John`s Wort
Valerian extract

Study placed in the following topic categories:

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

ClinicalTrials.gov processed this record on January 16, 2009