Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD) - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Controlled Trial of an Herbal Treatment for Juvenile Attention Deficit Hyperactivity Disorder

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

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
Experimental: A Herbal treatment	Drug: Hypericum perforatum 300 mg capsule taken three times a day Other Name: St. John's Wort
Placebo Comparator: B	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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Wendy Weber, ND, MPH

Bastyr University

More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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

Adolescent
Child
Phytotherapy

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012