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

Tracking Information

First Received Date ^ICMJE

December 28, 2004

Last Updated Date

October 24, 2007

Start Date ^ICMJE

February 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

ADHD-IV rating scale
side effects scale

Change History

Complete list of historical versions of study NCT00100295 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Official Title ^ICMJE

Controlled Trial of an Herbal Treatment for Juvenile Attention Deficit Hyperactivity Disorder

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Attention Deficit Hyperactivity Disorder

Intervention ^ICMJE

Drug: Hypericum perforatum
Other: Placebo

Study Arms / Comparison Groups

Experimental: Herbal treatment

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00100295

Responsible Party

Study ID Numbers ^ICMJE

K23 AT000929

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Wendy Weber, ND, MPH

Bastyr University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

October 2007

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