L-Theanine in the Management of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

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 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.
    

Intervention name(s): L-Theanine; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 400 mg/day, caps.; caps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective disorders; Theonine; Augmentation