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Effects of L-Theanine in Boys With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
L-theanine
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, attention, insomnia, hyperactivity, anxiety

Eligibility Criteria

8 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of attention deficit hyperactivity disorder (ADHD) Exclusion Criteria: -

Sites / Locations

  • Canadian Center for Functional Medicine

Outcomes

Primary Outcome Measures

Cognitive performance

Secondary Outcome Measures

Sleep quality, hyperactive behaviors, anxiety

Full Information

First Posted
February 9, 2006
Last Updated
April 28, 2008
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00291070
Brief Title
Effects of L-Theanine in Boys With ADHD
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 Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, attention, insomnia, hyperactivity, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-theanine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive performance
Secondary Outcome Measure Information:
Title
Sleep quality, hyperactive behaviors, anxiety

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of attention deficit hyperactivity disorder (ADHD) Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Michael Lyon
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Center for Functional Medicine
City
Coquitlam
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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Effects of L-Theanine in Boys With ADHD

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