Effects of L-Theanine in Boys With ADHD - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00291070

Purpose

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	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: L-theanine	Phase II

MedlinePlus related topics: Anxiety Attention Deficit Hyperactivity Disorder

Drug Information available for: Amino acids, branched-chain Theanine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Cognitive performance [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sleep quality, hyperactive behaviors, anxiety [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	8 Years to 12 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of attention deficit hyperactivity disorder (ADHD)

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291070

Locations

Canada, British Columbia
Canadian Center for Functional Medicine
Coquitlam, British Columbia, Canada

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Dr. Michael Lyon

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Michael Lyon )
Study ID Numbers:	C04-0605
Study First Received:	February 9, 2006
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00291070
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

ADHD
attention
insomnia
hyperactivity
anxiety

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009