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Effects of L-Theanine in Boys With ADHD

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ClinicalTrials.gov Identifier: NCT00291070
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : May 6, 2008
Sponsor:
Information provided by:
University of British Columbia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: L-theanine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized Placebo Controlled Clinical Trial Examining the Effects of L-Theanine (Suntheanine®) in Male Child Subjects With Attention Deficit Hyperactivity Disorder
Study Start Date : October 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Theanine

Arms and Interventions
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Intervention Details:
  • Drug: L-theanine
    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.

Outcome Measures
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Primary Outcome Measures :
  1. Cognitive performance

Secondary Outcome Measures :
  1. Sleep quality, hyperactive behaviors, anxiety

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Diagnosis of attention deficit hyperactivity disorder (ADHD)

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291070


Locations
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Canada, British Columbia
Canadian Center for Functional Medicine
Coquitlam, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Dr. Michael Lyon University of British Columbia
More Information
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Responsible Party: Dr. Michael Lyon, University of British Columbia
ClinicalTrials.gov Identifier: NCT00291070    
Other Study ID Numbers: C04-0605
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: April 2008
Keywords provided by University of British Columbia:
ADHD
attention
insomnia
hyperactivity
anxiety
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases