Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372151
Status:
COMPLETED
Last Update Posted:
2008-12-16
First Post:
2006-09-05
Brief Title:
L-Theanine in the Management of Schizophrenia
Sponsor:
Shaar Menashe Mental Health Center
Organization:
Shaar Menashe Mental Health Center
Study Overview
Official Title:
The Value of Augmenting L-Theanine in the Management of Schizophrenia A Randomized Double-Blind Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the proposed study is to investigate the efficacy and safety of add-on gamma-glutamylethylamide L-theanine versus a placebo for antipsychotic treatment for 8 weeks in a randomized double-blind parallel group study of 60 patients with schizophrenia and schizoaffective disorders
Detailed Description:
This is a two-year randomized placebo-controlled double-blind investigation of the use of augmentative L-theanine in the management of 60 patients with schizophrenia and schizoaffective disorders We will investigate several outcome variables in these patients including the positive and negative symptoms affective features emotional distress neuropsychological testing side effects and the quality of life Participating subjects on stable antipsychotic treatment will be randomized to receive for 8 weeks either L-theanine 400 mgday or a placebo in addition to regular ongoing antipsychotic medication for 8 weeks Subjects will be assessed at baseline and after 2 4 6 and 8 weeks of treatment using psychiatric rating scales self-reported questionnaires and a neuropsychological battery of tests The efficacy and safety of augmenting antipsychotic treatment with L-theanine will be analyzed
The Cambridge Neuropsychological Test Automated Battery CANTAB will be administered at commencement and completion of the study The CANTAB battery consists of a series of interrelated computerized tests of visual and movement skills attention and memory and executive function administered via a touch sensitive screen The nonverbal nature of the CANTAB tests makes them largely language independent and culture free These tests are run on an IBM-compatible personal computer with a touch-sensitive screen Neuropsychological testing lasts approximately 2 hours Subjects complete the tests in a fixed order with a break half-way through the testing session For a description of the nature of these tests the performance measures used and how the test scores are derived see httpwwwcantabcomcantabsitehomeacds The neuropsychological tests are categorized onto five cognitive domains visual and movement skills attention memory learning sustained attention and executive function Motor Screening BigLittle Circle Reaction Time Matching to Sample Visual Search Delayed Matching to Sample Pattern Recognition Memory Spatial Recognition Memory Spatial Span Rapid visual information processing Spatial working memory IntraExtra Dimensional Set Shift and Stockings of Cambridge In addition to raw scores from these tasks the average value of the z-scores of the CANTAB neurocognitive tasks will be used to determine cognitive indices in specific domains
The Cambridge Neuropsychological Test Automated Battery CANTAB will be administered at commencement and completion of the study The CANTAB battery consists of a series of interrelated computerized tests of visual and movement skills attention and memory and executive function administered via a touch sensitive screen The nonverbal nature of the CANTAB tests makes them largely language independent and culture free These tests are run on an IBM-compatible personal computer with a touch-sensitive screen Neuropsychological testing lasts approximately 2 hours Subjects complete the tests in a fixed order with a break half-way through the testing session For a description of the nature of these tests the performance measures used and how the test scores are derived see httpwwwcantabcomcantabsitehomeacds The neuropsychological tests are categorized onto five cognitive domains visual and movement skills attention memory learning sustained attention and executive function Motor Screening BigLittle Circle Reaction Time Matching to Sample Visual Search Delayed Matching to Sample Pattern Recognition Memory Spatial Recognition Memory Spatial Span Rapid visual information processing Spatial working memory IntraExtra Dimensional Set Shift and Stockings of Cambridge In addition to raw scores from these tasks the average value of the z-scores of the CANTAB neurocognitive tasks will be used to determine cognitive indices in specific domains
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None