- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00291070
Effects of L-Theanine in Boys With ADHD
April 28, 2008 updated by: University of British Columbia
A Double Blind, Randomized Placebo Controlled Clinical Trial Examining the Effects of L-Theanine (Suntheanine®) in Male Child Subjects With Attention Deficit Hyperactivity Disorder
This study will examine the effects of L-theanine (an amino acid found in green tea) on the behavior, cognitive performance and sleep quality of boys with ADHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Coquitlam, British Columbia, Canada
- Canadian Center for Functional Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Diagnosis of attention deficit hyperactivity disorder (ADHD)
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cognitive performance
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Secondary Outcome Measures
Outcome Measure |
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Sleep quality, hyperactive behaviors, anxiety
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Michael Lyon, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
February 9, 2006
First Submitted That Met QC Criteria
February 9, 2006
First Posted (Estimate)
February 13, 2006
Study Record Updates
Last Update Posted (Estimate)
May 6, 2008
Last Update Submitted That Met QC Criteria
April 28, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C04-0605
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.