L-Theanine in the Management of Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Value of Augmenting L-Theanine in the Management of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372151
• Other study ID #: Theanine 10/2006.ctil
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2006
• Last updated: December 15, 2008
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Sha’ar Menashe Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Dietary Supplement:
• L-Theanine
400 mg/day, caps.

Other:
• Placebo
caps.

Locations

Country	Name	City	State
Israel	Be'er Sheva Mental Health Center	Be'er Sheva
Israel	Sha'ar Menashe Mental Health Center	Hadera

Sponsors (3)

Lead Sponsor	Collaborator
Sha’ar Menashe Mental Health Center	Beersheva Mental Health Center, Stanley Medical Research Institute

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Clinical Global Impression Scale		every two weeks	No
Primary	The Positive and Negative Syndrome Scale		every two weeks	No
Primary	The Scale for the Assessment of Negative Symptoms		every two weeks	No
Primary	The Calgary Depression Scale for Schizophrenia		every two weeks	No
Primary	The Hamilton Scale for Anxiety		every two weeks	No
Primary	Cambridge Neuropsychological Test Automated Battery (CANTAB)		every 4 weeks	No
Secondary	The Global Assessment of Functioning		every two weeks	No
Secondary	The Talbieh Brief Distress Inventory		every two weeks	No
Secondary	The State/Trait Anxiety Inventory		every two weeks	No
Secondary	The Quality of Life Scale		every two weeks	No
Secondary	The Quality of Life Enjoyment and Satisfaction Questionnaire		every two weeks	No
Secondary	The Extrapyramidal Symptom Rating Scale		every two weeks	Yes
Secondary	Barnes Akathisia Scale		every two weeks	Yes