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

NCT ID: NCT00782080

Last Updated: 2014-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-06-30

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sedariston

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.

Group Type: EXPERIMENTAL

Sedariston

Intervention Type: DRUG

St. John´s Wort (100 mg) Valerian Extract (50 mg)

Placebo campsule

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Sedariston

St. John´s Wort (100 mg) Valerian Extract (50 mg)

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Sedariston Concentrate(R)

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steiner Arzneimittel, Berlin, Germany

UNKNOWN

Sponsor Role: collaborator

Prof. Huss

OTHER

Sponsor Role: lead

Responsible Party

Prof. Huss

Prof. Dr. med. Dipl.-Psych. Michael Huss

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Huss, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry

Locations

Rheinhessenfachklinik

Alzey, , Germany

DRK Fachklinik für Kinder- und Jugendpsychiatrie

Bad Neuenahr, , Germany

Praxis für Kinder- und Jugendpsychiatrie

Berlin, , Germany

Charité University

Berlin, , Germany

Johannes Gutenberg University

Mainz, , Germany

Countries

Germany

Other Identifiers

Stei-Sed-0106

Identifier Type: -

Identifier Source: org_study_id