Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT00100295

Last Updated: 2007-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Keywords

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Adolescent Child Phytotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Herbal treatment

Group Type EXPERIMENTAL

Hypericum perforatum

Intervention Type DRUG

300 mg capsule taken three times a day

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Hypericum perforatum

300 mg capsule taken three times a day

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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St. John's Wort

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Wendy Weber, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

Bastyr University

Locations

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Bastyr University

Kenmore, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18544723 (View on PubMed)

Other Identifiers

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K23AT000929

Identifier Type: NIH

Identifier Source: org_study_id

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