Effects of L-Theanine in Boys With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291070
• Other study ID #: C04-0605
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2006
• Last updated: April 28, 2008
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: April 2008
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

Diagnosis of attention deficit hyperactivity disorder (ADHD)

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
Canada	Canadian Center for Functional Medicine	Coquitlam	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance		Unspecified	No
Secondary	Sleep quality, hyperactive behaviors, anxiety		Unspecified	No