Clinical trial NCT00782080: Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Keywords: ADHD
children
adolescents
St. John's Wort
Valerian extract
Safety
Efficacy
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Steiner Arzneimittel, Berlin, Germany
First posted: 2008-10-31
Enrollment: 155
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: ADHD-IV rating scale
timeFrame: Difference in total score between baseline and end of study
Secondary outcomes:
measure: Barkley´s Side Effects Rating Scale
timeFrame: Difference between baseline and each visit
Other outcomes:
Locations:
city: Alzey
country: Germany
facility: Rheinhessenfachklinik
city: Bad Neuenahr
country: Germany
facility: DRK Fachklinik für Kinder- und Jugendpsychiatrie
city: Berlin
country: Germany
facility: Praxis für Kinder- und Jugendpsychiatrie
city: Berlin
country: Germany
facility: Charité University
city: Mainz
country: Germany
facility: Johannes Gutenberg University
Study officials:
affiliation: Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
name: Michael Huss, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: