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

NCT00782080 | Completed Phase 3 DMC

• 1 other identifier: Stei-Sed-0106
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 5

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

Conditions

ADHD

Keywords

ADHD; children; adolescents; St. John's Wort; Valerian extract; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• ADHD-IV rating scale

  Difference in total score between baseline and end of study

Secondary Outcomes (1)

• Barkley´s Side Effects Rating Scale

  Difference between baseline and each visit

Study Arms (2)

Sedariston

EXPERIMENTAL

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

Placebo campsule

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sedariston DRUG

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

Also known as: Sedariston Concentrate(R)

Sedariston

Placebo DRUG

Placebo

Placebo campsule

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Huss: lead
• Steiner Arzneimittel, Berlin, Germany: collaborator

Study Sites (5)

Rheinhessenfachklinik

Alzey, 55232, Germany

Location

DRK Fachklinik für Kinder- und Jugendpsychiatrie

Bad Neuenahr, 53474, Germany

Location

Praxis für Kinder- und Jugendpsychiatrie

Berlin, 10789, Germany

Location

Charité University

Berlin, 13353, Germany

Location

Johannes Gutenberg University

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Michael Huss, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Dipl.-Psych. Michael Huss

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

DE (5)