Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

October 24, 2007 updated by: National Center for Complementary and Integrative Health (NCCIH)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Other: Placebo
300 mg given three times a day, containing rice protein powder
Experimental: A
Herbal treatment
Drug: Hypericum perforatum
300 mg capsule taken three times a day
Other Names:
  • St. John's Wort

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

December 28, 2004

First Submitted That Met QC Criteria

December 28, 2004

First Posted (Estimate)

December 29, 2004

Study Record Updates

Last Update Posted (Estimate)

October 26, 2007

Last Update Submitted That Met QC Criteria

October 24, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23AT000929 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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