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

Prof. Huss

Status and phase: Completed; Phase 3

Conditions: ADHD

Treatments: Drug: Sedariston; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00782080

Stei-Sed-0106

Details and patient eligibility

About

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

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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155 participants in 2 patient groups, including a placebo group

Sedariston

Experimental group

Description:

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.

Treatment:

Drug: Sedariston

Placebo campsule

Placebo Comparator group

Description:

Placebo provided by the company given orally in capsules (size 1 )twice daily

Treatment:

Drug: Placebo