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Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hypericum perforatum

Placebo

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Adolescent, Child, Phytotherapy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bastyr University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Herbal treatment

Outcomes

Primary Outcome Measures

ADHD-IV rating scale

side effects scale

Secondary Outcome Measures

Child Behavior Checklist, Youth Self Report Form

Full Information

NCT ID

NCT00100295

First Posted

December 28, 2004

Last Updated

October 24, 2007

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00100295

Brief Title

Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

Adolescent, Child, Phytotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Herbal treatment

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Hypericum perforatum

Other Intervention Name(s)

St. John's Wort

Intervention Description

300 mg capsule taken three times a day

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

300 mg given three times a day, containing rice protein powder

Primary Outcome Measure Information:

Title

ADHD-IV rating scale

Time Frame

Difference between baseline and end of study

Title

side effects scale

Time Frame

Freqency of events during entire study

Secondary Outcome Measure Information:

Title

Child Behavior Checklist, Youth Self Report Form

Time Frame

Baseline and end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wendy Weber, ND, MPH

Organizational Affiliation

Bastyr University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bastyr University

City

Kenmore

State/Province

Washington

ZIP/Postal Code

98028

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18544723

Citation

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. doi: 10.1001/jama.299.22.2633.

Results Reference

derived

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Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

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