Clinical Trial: Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

This study is not yet open for patient recruitment.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

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.

Condition Treatment or Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: Hypericum perforatum
Phase II

MedlinePlus related topics:  Attention Deficit Disorder with Hyperactivity

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Controlled Trial of Hypericum for Juvenile Attention Deficit Hyperactivity Disorder

Further Study Details: 
Primary Outcomes: ADHD-IV rating scale; side effects scale
Expected Total Enrollment:  58

Study start: February 2005;  Expected completion: March 2007
Last follow-up: January 2007;  Data entry closure: January 2007

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.

Eligibility

Ages Eligible for Study:  6 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

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

Location Information

Wendy Weber, ND, MPH      425-602-3419    wendyw@bastyr.edu

Washington
      Bastyr University, Kenmore,  Washington,  98028,  United States
Wendy Weber, ND, MPH  425-602-3419    wendyw@bastyr.edu 
Wendy Weber, ND, MPH,  Principal Investigator

Study chairs or principal investigators

Wendy Weber, ND, MPH,  Principal Investigator,  Bastyr University   

More Information

Study ID Numbers:  K23AT00929
Record last reviewed:  December 2004
Last Updated:  December 28, 2004
Record first received:  December 28, 2004
ClinicalTrials.gov Identifier:  NCT00100295
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005