Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 2

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Hypericum perforatum; Other: Placebo

• Registration Number: NCT00100295
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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 Timeline

• Study First Submitted: 2004-12-28
• Study First Submitted QC: 2004-12-28
• Study First Posted: 2004-12-29
• Study Start: 2005-02
• Study Completion: 2006-11
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-24
• Last Update Posted: 2007-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Hypericum perforatum	Herbal treatment
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
side effects scale	Freqency of events during entire study
ADHD-IV rating scale	Difference between baseline and end of study

Secondary Outcome Measures

Name	Time	Method
Child Behavior Checklist, Youth Self Report Form	Baseline and end of study

Trial Locations

Locations (1)

Bastyr University; 🇺🇸 Kenmore, Washington, United States