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Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00100295
First received: December 28, 2004
Last updated: October 24, 2007
Last verified: October 2007
History of Changes

December 28, 2004
October 24, 2007
February 2005
Not Provided
  • ADHD-IV rating scale [ Time Frame: Difference between baseline and end of study ]
  • side effects scale [ Time Frame: Freqency of events during entire study ]
  • ADHD-IV rating scale
  • side effects scale
Complete list of historical versions of study NCT00100295 on ClinicalTrials.gov Archive Site
Child Behavior Checklist, Youth Self Report Form [ Time Frame: Baseline and end of study ]
Not Provided
Not Provided
Not Provided
 
Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Controlled Trial of an Herbal Treatment for Juvenile Attention Deficit Hyperactivity Disorder

The purpose of this study is to determine the safety and effectiveness of an herbal product for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents.

ADHD is a common childhood disorder associated with concentration problems and disruptive behavior. Evidence suggests that herbal remedies may be as effective as standard drug therapies in treating ADHD symptoms. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.

This study will last 9 weeks. Participants will be randomly assigned to receive either an herbal product or placebo three times a day for the duration of the study. Participants will come in for weekly study visits at which their ADHD symptoms and any side effects will be assessed by self-report rating scales.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Hypericum perforatum
    300 mg capsule taken three times a day
    Other Name: St. John's Wort
  • Other: Placebo
    300 mg given three times a day, containing rice protein powder
  • Experimental: A
    Herbal treatment
    Intervention: Drug: Hypericum perforatum
  • Placebo Comparator: B
    Intervention: Other: Placebo
Weber W, Vander Stoep A, McCarty RL, Weiss NS, Biederman J, McClellan J. Hypericum perforatum (St John's wort) for attention-deficit/hyperactivity disorder in children and adolescents: a randomized controlled trial. JAMA. 2008 Jun 11;299(22):2633-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
November 2006
Not Provided

Inclusion Criteria:

  • Diagnosis of ADHD
  • Score of greater than 1.5 standard deviation above the age and gender norms on the ADHD-IV rating scale
  • Parents and children can understand English
  • Parents and children willing to attend all study visits
  • Able to swallow study medication
  • Willing to use acceptable methods of contraception

Exclusion Criteria:

  • Severe depression
  • History of bipolar disorder, psychosis, severe conduct disorder, or other serious medical conditions
  • Use of medications that may interact with the herbal product
  • Current use of medications to treat ADHD
  • Previous use of Hypericum
  • Pregnancy
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100295
K23 AT000929
Yes
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Wendy Weber, ND, MPH Bastyr University
National Center for Complementary and Alternative Medicine (NCCAM)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP