L-Theanine in the Management of Schizophrenia
The Value of Augmenting L-Theanine in the Management of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started Oct 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2006
CompletedFirst Posted
Study publicly available on registry
September 6, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 16, 2008
December 1, 2008
2.2 years
September 5, 2006
December 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
The Clinical Global Impression Scale
every two weeks
The Positive and Negative Syndrome Scale
every two weeks
The Scale for the Assessment of Negative Symptoms
every two weeks
The Calgary Depression Scale for Schizophrenia
every two weeks
The Hamilton Scale for Anxiety
every two weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB)
every 4 weeks
Secondary Outcomes (7)
The Global Assessment of Functioning
every two weeks
The Talbieh Brief Distress Inventory
every two weeks
The State/Trait Anxiety Inventory
every two weeks
The Quality of Life Scale
every two weeks
The Quality of Life Enjoyment and Satisfaction Questionnaire
every two weeks
- +2 more secondary outcomes
Study Arms (2)
L-Theanine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 18-60 years, men or women
- 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.
You may not qualify if:
- 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.
- Renal disease
- Hepatic dysfunction
- Pregnant women
- Patients receiving mood stabilizing medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sha'ar Menashe Mental Health Centerlead
- Stanley Medical Research Institutecollaborator
- Beersheva Mental Health Centercollaborator
Study Sites (2)
Be'er Sheva Mental Health Center
Beersheba, Israel
Sha'ar Menashe Mental Health Center
Hadera, 38814, Israel
Related Publications (4)
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: 16493792BACKGROUNDYokogoshi 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: 10978861BACKGROUNDMiodownik 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: 21617527DERIVEDRitsner 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.
PMID: 21208586DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S Ritsner, MD, PhD
Sha'ar Menashe Mental Health Center
- STUDY DIRECTOR
Yael Ratner, MD
Sha'ar Menashe Mental Health Center
- STUDY DIRECTOR
Anatoly Gibel, MD
Sha'ar Menashe Mental Health Center
- STUDY DIRECTOR
Chanoch Miodownik, MD
Be'er Sheva Mental Health Center
- STUDY DIRECTOR
Tatyana Shleifer, MD
Be'er Sheva Mental Health Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 5, 2006
First Posted
September 6, 2006
Study Start
October 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
December 16, 2008
Record last verified: 2008-12