Herbal Treatment for Attention Deficit Hyperactivity Diso... | NCT00100295

Studies
Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

NCT00100295

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Oct 26, 2007Estimated

Enrollment

59Actual

Phase

Phase 2

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Hypericum perforatum
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Dec 28, 2004

First Submission Date that Met QC Criteria

Dec 28, 2004

First Posted Date

Dec 29, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2007

Last Update Posted Date

Oct 26, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Herbal treatment	Drug: Hypericum perforatum
B	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypericum perforatum	Drug	300 mg capsule taken three times a day	A

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wendy Weber, ND, MPH	Bastyr University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bastyr University		Kenmore	Washington	98028	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18544723	Derived	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.

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders