NCT00100295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2004

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

October 26, 2007

Status Verified

October 1, 2007

First QC Date

December 28, 2004

Last Update Submit

October 24, 2007

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

AdolescentChildPhytotherapy

Outcome Measures

Primary Outcomes (2)

  • ADHD-IV rating scale

    Difference between baseline and end of study

  • side effects scale

    Freqency of events during entire study

Secondary Outcomes (1)

  • Child Behavior Checklist, Youth Self Report Form

    Baseline and end of study

Study Arms (2)

A

EXPERIMENTAL

Herbal treatment

Drug: Hypericum perforatum

B

PLACEBO COMPARATOR
Other: Placebo

Interventions

Hypericum perforatumDRUG

300 mg capsule taken three times a day

Also known as: St. John's Wort
A
PlaceboOTHER

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

B

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bastyr University

Kenmore, Washington, 98028, United States

Location

Related Publications (1)

  • 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.

    PMID: 18544723DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wendy Weber, ND, MPH

    Bastyr University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 28, 2004

First Posted

December 29, 2004

Study Start

February 1, 2005

Study Completion

November 1, 2006

Last Updated

October 26, 2007

Record last verified: 2007-10

Locations

US(1)