Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of St. John´s Wort/Valerian Extract (Sedariston Concentrate) Versus Placebo in Children and Adolescents With Attention Deficit/Hyperactivity Disorder (ADHD)

Conditions
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ADHD

Intervention / Treatment
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* Drug: Sedariston
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedariston<br>Sedariston (100 mg St. John´s Wort and 50 mg Valerian extract) capsule given orally in capsules (size 1) twice daily for eight weeks in children (6-11): 1 - 0 -1 In Adolescents (12-17 years) two capsules (size 1) twice daily: 2 - 0 - 2. | Drug: Sedariston<br>* St. John´s Wort (100 mg) Valerian Extract (50 mg)<br>* Other names: Sedariston Concentrate(R);|
| Placebo Comparator: Placebo campsule<br>Placebo provided by the company given orally in capsules (size 1 )twice daily | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-IV rating scale |  | Difference in total score between baseline and end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barkley´s Side Effects Rating Scale |  | Difference between baseline and each visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, children, adolescents, St. John's Wort, Valerian extract, Safety, Efficacy