Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100295
• Other study ID #: K23AT000929
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2004
• Last updated: October 24, 2007
• Start date: February 2005
• Est. completion date: November 2006

Study information

• Verified date: October 2007
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Hypericum perforatum
300 mg capsule taken three times a day

Other:
• Placebo
300 mg given three times a day, containing rice protein powder

Locations

Country	Name	City	State
United States	Bastyr University	Kenmore	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-IV rating scale		Difference between baseline and end of study
Primary	side effects scale		Freqency of events during entire study
Secondary	Child Behavior Checklist, Youth Self Report Form		Baseline and end of study