Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01047592
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : July 8, 2014
China Medical University Hospital
Information provided by (Responsible Party):
Chun Yuan Lin , MD, Chang-Hua Hospital

January 12, 2010
January 13, 2010
July 8, 2014
March 2009
December 2013   (Final data collection date for primary outcome measure)
Positive, negative, cognitive symptoms of schizophrenia, laboratory tests. [ Time Frame: 12 weeks ]
Positive, negative, cognitive symptoms of schizophrenia, metabolic syndrome parameters [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01047592 on Archive Site
The subscales of PANSS,MATRICS, and serum DAAO levels. [ Time Frame: 12 weeks ]
The subscales of PANSS and SANS [ Time Frame: 12 weeks ]
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Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia
N-methyl-D-aspartate (NMDA) Enhancers' Benefit to Schizophrenia Treatment
Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated clinical benefits for schizophrenia patients. This project aims to compare the efficacy and safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2 g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were determined at the beginning and the end of the study. The efficacies of three groups are compared, and the characteristics of better responders are analyzed.

We will measure clinical efficacy every 3 weeks during the treatment. At the beginning and the end of the trial,We will utilize a battery of tests to assess the effect of the treatment on cognitive functions.The side effect assessments are also performed every 3 weeks. Side effect assessments include Simpson-Angus Rating Scale for extrapyramidal side-effects, Abnormal Involuntary Movement Scale (AIMS) for dyskinesia, and Barnes Akathisia Scale. Systemic side effects are reviewed by applying the Udvalg for Kliniske Undersogelser (UKU) Side-effects Rating Scale. DAAO level, routine laboratory tests, including CBC, biochemistry , urine analysis, and EKG, will be checked at baseline and the end of week 12.

To compare the metabolic syndrome parameters among groups, body mass index, hip size, waist size, blood pressure, fasting blood sugar, triglyceride, and total-cholesterol will be checked at baseline and the end of the study.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: sarcosine
    sarcosine, 2 g/d , oral, for 12 weeks
  • Drug: sarcosine+ BE
    sarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks
  • Drug: placebo
    placebo,oral, for 12 weeks
  • Active Comparator: sarcosine
    Intervention: Drug: sarcosine
  • Active Comparator: sarcosine+ BE
    Intervention: Drug: sarcosine+ BE
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • The participants fulfill the criteria of schizophrenia according to the
  • Diagnostic and Statistic Manual, fourth edition (DSM-IV).
  • The participants remain stable schizophrenic symptoms and receive stable antipsychotic regimens at last 8 weeks before enrollment.
  • The participants agree to participate in the study and provide informed consent.

Exclusion Criteria:

  • History of alcohol or substance dependence, history of epilepsy, head trauma or CNS diseases, history of major, untreated medical diseases, mental retardation, pregnancy or lactation
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
HAC9814 ( Other Identifier: Hospital Adminstration Comission, DOH, Taiwan )
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Chun Yuan Lin , MD, Chang-Hua Hospital
Chang-Hua Hospital
China Medical University Hospital
Principal Investigator: Chun-yuan Lin, MD Changhua Hospital
Study Director: Hsien-yuan Lane, MD,PHD China Medical University Hospital
Chang-Hua Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP