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Completed

NCT Number: NCT00100295

Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bastyr University

Kenmore, Washington, 98028, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypericum perforatum

Drug

300 mg capsule taken three times a day

Other names: St. John's Wort

Placebo

Other

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

Primary outcomes

  1. ADHD-IV rating scale

    Time frame: Difference between baseline and end of study

  2. side effects scale

    Time frame: Freqency of events during entire study

Secondary outcomes

  1. Child Behavior Checklist, Youth Self Report Form

    Time frame: Baseline and end of study

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Dec 29, 2004
Registry last updated
Oct 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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