Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2006-10-31
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 (http://www.cantab.com/cantab/site/home.acds). The neuropsychological tests are categorized onto five cognitive domains: visual and movement skills, attention, memory, learning, sustained attention, and executive function: Motor Screening, Big/Little 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, Intra/Extra 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
L-Theanine
L-Theanine
400 mg/day, caps.
Placebo
Placebo
caps.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
L-Theanine
400 mg/day, caps.
Placebo
caps.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* DSM-IV criteria for schizophrenia or schizoaffective disorder
* At least 4 on the Clinical Global Impression Scale
* At least two weeks of ongoing treatment with current antipsychotic agents.
* Ability and willingness to sign an informed consent form for participation in the study.
Exclusion Criteria
* Renal disease
* Hepatic dysfunction
* Pregnant women
* Patients receiving mood stabilizing medications.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanley Medical Research Institute
OTHER
Beersheva Mental Health Center
OTHER_GOV
Sha'ar Menashe Mental Health Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Technion
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael S Ritsner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sha'ar Menashe Mental Health Center
Yael Ratner, MD
Role: STUDY_DIRECTOR
Sha'ar Menashe Mental Health Center
Anatoly Gibel, MD
Role: STUDY_DIRECTOR
Sha'ar Menashe Mental Health Center
Chanoch Miodownik, MD
Role: STUDY_DIRECTOR
Be'er Sheva Mental Health Center
Tatyana Shleifer, MD
Role: STUDY_DIRECTOR
Be'er Sheva Mental Health Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Be'er Sheva Mental Health Center
Beersheba, , Israel
Sha'ar Menashe Mental Health Center
Hadera, , Israel
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yamada T, Terashima T, Okubo T, Juneja LR, Yokogoshi H. Effects of theanine, r-glutamylethylamide, on neurotransmitter release and its relationship with glutamic acid neurotransmission. Nutr Neurosci. 2005 Aug;8(4):219-26. doi: 10.1080/10284150500170799.
Yokogoshi H, Terashima T. Effect of theanine, r-glutamylethylamide, on brain monoamines, striatal dopamine release and some kinds of behavior in rats. Nutrition. 2000 Sep;16(9):776-7. doi: 10.1016/s0899-9007(00)00384-1. No abstract available.
Miodownik C, Maayan R, Ratner Y, Lerner V, Pintov L, Mar M, Weizman A, Ritsner MS. Serum levels of brain-derived neurotrophic factor and cortisol to sulfate of dehydroepiandrosterone molar ratio associated with clinical response to L-theanine as augmentation of antipsychotic therapy in schizophrenia and schizoaffective disorder patients. Clin Neuropharmacol. 2011 Jul-Aug;34(4):155-60. doi: 10.1097/WNF.0b013e318220d8c6.
Ritsner MS, Miodownik C, Ratner Y, Shleifer T, Mar M, Pintov L, Lerner V. L-theanine relieves positive, activation, and anxiety symptoms in patients with schizophrenia and schizoaffective disorder: an 8-week, randomized, double-blind, placebo-controlled, 2-center study. J Clin Psychiatry. 2011 Jan;72(1):34-42. doi: 10.4088/JCP.09m05324gre. Epub 2010 Nov 30.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Theanine 10/2006.ctil
Identifier Type: -
Identifier Source: org_study_id