NCT00291070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

May 6, 2008

Status Verified

April 1, 2008

Enrollment Period

9 months

First QC Date

February 9, 2006

Last Update Submit

April 28, 2008

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDattentioninsomniahyperactivityanxiety

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

Secondary Outcomes (1)

  • Sleep quality, hyperactive behaviors, anxiety

Interventions

L-theanineDRUG

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 Criteria

Age8 Years - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of attention deficit hyperactivity disorder (ADHD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canadian Center for Functional Medicine

Coquitlam, British Columbia, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySleep Initiation and Maintenance DisordersSpasmAnxiety Disorders

Interventions

theanine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. Michael Lyon

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 13, 2006

Study Start

October 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

May 6, 2008

Record last verified: 2008-04

Locations

CA(1)