Effects of L-Theanine in Boys With ADHD
This study has been completed.
Sponsor:
University of British Columbia
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
| Tracking Information | |||||
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| First Received Date ICMJE | February 9, 2006 | ||||
| Last Updated Date | April 28, 2008 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cognitive performance [ Time Frame: Unspecified ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Cognitive performance | ||||
| Change History | Complete list of historical versions of study NCT00291070 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Sleep quality, hyperactive behaviors, anxiety [ Time Frame: Unspecified ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Sleep quality, hyperactive behaviors, anxiety | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of L-Theanine in Boys With ADHD | ||||
| Official Title ICMJE | A Double Blind, Randomized Placebo Controlled Clinical Trial Examining the Effects of L-Theanine (Suntheanine®) in Male Child Subjects With Attention Deficit Hyperactivity Disorder | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Diagnosis of attention deficit hyperactivity disorder (ADHD) Exclusion Criteria: - |
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| Gender | Male | ||||
| Ages | 8 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00291070 | ||||
| Other Study ID Numbers ICMJE | C04-0605 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Dr. Michael Lyon, University of British Columbia | ||||
| Study Sponsor ICMJE | University of British Columbia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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