Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Hypericum perforatum
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Herbal treatment | Drug: Hypericum perforatum<br>* 300 mg capsule taken three times a day<br>* Other names: St. John's Wort;|
| Placebo Comparator: B<br> | Other: Placebo<br>* 300 mg given three times a day, containing rice protein powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-IV rating scale |  | Difference between baseline and end of study | 
| side effects scale |  | Freqency of events during entire study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behavior Checklist, Youth Self Report Form |  | Baseline and end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Child, Phytotherapy