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Effects of L-Theanine in Boys With ADHD

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00291070
First received: February 9, 2006
Last updated: April 28, 2008
Last verified: April 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Theanine
U.S. FDA Resources

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:
    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.
  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

No publications provided

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

Keywords provided by University of British Columbia:
ADHD
attention
insomnia
hyperactivity
anxiety

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013