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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: sarcosine Drug: sarcosine+ BE Drug: placebo Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-methyl-D-aspartate (NMDA) Enhancers' Benefit to Schizophrenia Treatment
Study Start Date : March 2009
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: sarcosine Drug: sarcosine
sarcosine, 2 g/d , oral, for 12 weeks
Active Comparator: sarcosine+ BE Drug: sarcosine+ BE
sarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks
Placebo Comparator: Placebo Drug: placebo
placebo,oral, for 12 weeks

Primary Outcome Measures :
  1. Positive, negative, cognitive symptoms of schizophrenia, laboratory tests. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The subscales of PANSS,MATRICS, and serum DAAO levels. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01047592

Changhua Hospital
Changhua, Taiwan, 513
Sponsors and Collaborators
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

Responsible Party: Chun Yuan Lin , MD, Attending, Chang-Hua Hospital Identifier: NCT01047592     History of Changes
Other Study ID Numbers: DMR98-IR-014
HAC9814 ( Other Identifier: Hospital Adminstration Comission, DOH, Taiwan )
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by Chun Yuan Lin , MD, Chang-Hua Hospital:
cognitive function
N-methyl-D-aspartate receptor

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs