Attention Deficit Hyperactivity DisorderPhase 2NCT00291070
Effects of L-Theanine in Boys With ADHD
A Phase 2 study testing L-theanine in people with Attention Deficit Hyperactivity Disorder, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years, men only
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- L-theanine
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of attention deficit hyperactivity disorder (ADHD)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
Canadian Center for Functional Medicine
Coquitlam, British Columbia
About this 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
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- L-theanine
- Keywords
- ADHD, attention, insomnia, hyperactivity, anxiety
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Sleep Initiation and Maintenance Disorders, Spasm, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Secondary outcomes (1)
Sleep quality, hyperactive behaviors, anxiety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startOct 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Michael Lyon, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291070
- Sponsor's protocol ID
- C04-0605
- Status last verified
- Apr 2008
- First submitted
- 9 Feb 2006
- Last updated
- 6 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00291070
- Acronym / sponsor ID
- C04-0605
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, attention, insomnia, hyperactivity, anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 13 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of attention deficit hyperactivity disorder (ADHD)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-theanineThis 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. | Drug | – |
Primary outcome
Cognitive performance
1 secondary outcome
Sleep quality, hyperactive behaviors, anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Michael Lyon principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-theanine in people with Attention Deficit Hyperactivity Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2008.