Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT00372151
Status:
COMPLETED
Last Update Posted:
2008-12-16
First Post:
2006-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
L-Theanine in the Management of Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C026166', 'term': 'theanine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-15', 'studyFirstSubmitDate': '2006-09-05', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Clinical Global Impression Scale', 'timeFrame': 'every two weeks'}, {'measure': 'The Positive and Negative Syndrome Scale', 'timeFrame': 'every two weeks'}, {'measure': 'The Scale for the Assessment of Negative Symptoms', 'timeFrame': 'every two weeks'}, {'measure': 'The Calgary Depression Scale for Schizophrenia', 'timeFrame': 'every two weeks'}, {'measure': 'The Hamilton Scale for Anxiety', 'timeFrame': 'every two weeks'}, {'measure': 'Cambridge Neuropsychological Test Automated Battery (CANTAB)', 'timeFrame': 'every 4 weeks'}], 'secondaryOutcomes': [{'measure': 'The Global Assessment of Functioning', 'timeFrame': 'every two weeks'}, {'measure': 'The Talbieh Brief Distress Inventory', 'timeFrame': 'every two weeks'}, {'measure': 'The State/Trait Anxiety Inventory', 'timeFrame': 'every two weeks'}, {'measure': 'The Quality of Life Scale', 'timeFrame': 'every two weeks'}, {'measure': 'The Quality of Life Enjoyment and Satisfaction Questionnaire', 'timeFrame': 'every two weeks'}, {'measure': 'The Extrapyramidal Symptom Rating Scale', 'timeFrame': 'every two weeks'}, {'measure': 'Barnes Akathisia Scale', 'timeFrame': 'every two weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Schizoaffective disorders', 'Theonine', 'Augmentation'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '16493792', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10978861', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21617527', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '21208586', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 mg/day) 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60 years, men or women\n* DSM-IV criteria for schizophrenia or schizoaffective disorder\n* At least 4 on the Clinical Global Impression Scale\n* At least two weeks of ongoing treatment with current antipsychotic agents.\n* Ability and willingness to sign an informed consent form for participation in the study.\n\nExclusion Criteria:\n\n* Evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, Cushings disease, or thyroid disorder, mental retardation, alcohol or drug abuse.\n* Renal disease\n* Hepatic dysfunction\n* Pregnant women\n* Patients receiving mood stabilizing medications.'}, 'identificationModule': {'nctId': 'NCT00372151', 'briefTitle': 'L-Theanine in the Management of Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': "Sha'ar Menashe Mental Health Center"}, 'officialTitle': 'The Value of Augmenting L-Theanine in the Management of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Theanine 10/2006.ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-Theanine', 'interventionNames': ['Dietary Supplement: L-Theanine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'L-Theanine', 'type': 'DIETARY_SUPPLEMENT', 'description': '400 mg/day, caps.', 'armGroupLabels': ['L-Theanine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'caps.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': "Be'er Sheva Mental Health Center", 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '38814', 'city': 'Hadera', 'country': 'Israel', 'facility': "Sha'ar Menashe Mental Health Center", 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Michael S Ritsner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sha'ar Menashe Mental Health Center"}, {'name': 'Yael Ratner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Sha'ar Menashe Mental Health Center"}, {'name': 'Anatoly Gibel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Sha'ar Menashe Mental Health Center"}, {'name': 'Chanoch Miodownik, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Be'er Sheva Mental Health Center"}, {'name': 'Tatyana Shleifer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Be'er Sheva Mental Health Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sha'ar Menashe Mental Health Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanley Medical Research Institute', 'class': 'OTHER'}, {'name': 'Beersheva Mental Health Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Michael S Ritsner', 'oldOrganization': 'Technion'}}}}