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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 Measure ^†

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

Condition ^†

Attention Deficit Hyperactivity Disorder

Intervention ^†

Drug: Hypericum perforatum
Other: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

February 2005

Completion Date

November 2006

Eligibility 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

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00100295

Organization ID

K23 AT000929

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Wendy Weber, ND, MPH

Bastyr University

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

October 2007

First Received Date ^†

December 28, 2004

Last Updated Date

October 24, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.