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Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00100295
  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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Hypericum perforatum
Other: Placebo
Phase II

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Controlled Trial of an Herbal Treatment for Juvenile Attention Deficit Hyperactivity Disorder

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • ADHD-IV rating scale [ Time Frame: Difference between baseline and end of study ]
  • side effects scale [ Time Frame: Freqency of events during entire study ]

Secondary Outcome Measures:
  • Child Behavior Checklist, Youth Self Report Form [ Time Frame: Baseline and end of study ]

Enrollment:   59
Study Start Date:   February 2005
Study Completion Date:   November 2006

Arms Assigned Interventions
A: Experimental
Herbal treatment
Drug: Hypericum perforatum
300 mg capsule taken three times a day
B: Placebo Comparator Other: Placebo
300 mg given three times a day, containing rice protein powder

Detailed Description:

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 to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100295

Locations
United States, Washington
Bastyr University    
      Kenmore, Washington, United States, 98028

Sponsors and Collaborators

Investigators
Principal Investigator:     Wendy Weber, ND, MPH     Bastyr University    
  More Information


Publications indexed to this study:

Study ID Numbers:   K23 AT000929
First Received:   December 28, 2004
Last Updated:   October 24, 2007
ClinicalTrials.gov Identifier:   NCT00100295
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Adolescent  
Child  
Phytotherapy  

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on November 19, 2008




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