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

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

Sponsors

Lead Sponsor: Prof. Huss

Collaborator: Steiner Arzneimittel, Berlin, Germany

Source Johannes Gutenberg University Mainz
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.

Overall Status Completed
Start Date July 2008
Completion Date June 2010
Primary Completion Date March 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
ADHD-IV rating scale Difference in total score between baseline and end of study
Secondary Outcome
Measure Time Frame
Barkley´s Side Effects Rating Scale Difference between baseline and each visit
Enrollment 155
Condition
Intervention

Intervention Type: Drug

Intervention Name: Sedariston

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

Arm Group Label: Sedariston

Other Name: Sedariston Concentrate(R)

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo

Arm Group Label: Placebo campsule

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

Gender: All

Minimum Age: 6 Years

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Michael Huss, Prof. Dr. Principal Investigator Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
Location
Facility:
Rheinhessenfachklinik | Alzey, 55232, Germany
DRK Fachklinik für Kinder- und Jugendpsychiatrie | Bad Neuenahr, 53474, Germany
Praxis für Kinder- und Jugendpsychiatrie | Berlin, 10789, Germany
Charité University | Berlin, 13353, Germany
Johannes Gutenberg University | Mainz, 55131, Germany
Location Countries

Germany

Verification Date

March 2014

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Johannes Gutenberg University Mainz

Investigator Full Name: Prof. Huss

Investigator Title: Prof. Dr. med. Dipl.-Psych. Michael Huss

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Sedariston

Type: Experimental

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.

Label: Placebo campsule

Type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov