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

Primary Purpose

ADHD

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Sedariston
Placebo
Sponsored by
Prof. Huss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, children, adolescents, St. John's Wort, Valerian extract, Safety, Efficacy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Rheinhessenfachklinik
  • DRK Fachklinik für Kinder- und Jugendpsychiatrie
  • Praxis für Kinder- und Jugendpsychiatrie
  • Charité University
  • Johannes Gutenberg University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sedariston

Placebo campsule

Arm 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.

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

Outcomes

Primary Outcome Measures

ADHD-IV rating scale

Secondary Outcome Measures

Barkley´s Side Effects Rating Scale

Full Information

First Posted
October 29, 2008
Last Updated
March 12, 2014
Sponsor
Prof. Huss
Collaborators
Steiner Arzneimittel, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00782080
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Huss
Collaborators
Steiner Arzneimittel, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, children, adolescents, St. John's Wort, Valerian extract, Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sedariston
Arm Type
Experimental
Arm 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.
Arm Title
Placebo campsule
Arm Type
Placebo Comparator
Arm Description
Placebo provided by the company given orally in capsules (size 1 )twice daily
Intervention Type
Drug
Intervention Name(s)
Sedariston
Other Intervention Name(s)
Sedariston Concentrate(R)
Intervention Description
St. John´s Wort (100 mg) Valerian Extract (50 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
ADHD-IV rating scale
Time Frame
Difference in total score between baseline and end of study
Secondary Outcome Measure Information:
Title
Barkley´s Side Effects Rating Scale
Time Frame
Difference between baseline and each visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Huss, Prof. Dr.
Organizational Affiliation
Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheinhessenfachklinik
City
Alzey
ZIP/Postal Code
55232
Country
Germany
Facility Name
DRK Fachklinik für Kinder- und Jugendpsychiatrie
City
Bad Neuenahr
ZIP/Postal Code
53474
Country
Germany
Facility Name
Praxis für Kinder- und Jugendpsychiatrie
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Charité University
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Johannes Gutenberg University
City
Mainz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

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

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