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

NCT00782080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2014-03-13

No results posted yet for this study

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

Interventions

DRUG

Sedariston

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

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Steiner Arzneimittel, Berlin, Germany

    collaborator UNKNOWN

  • Prof. Huss

    lead OTHER

Principal Investigators

  • Michael Huss, Prof. Dr. · Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00782080 on ClinicalTrials.gov