Skip to main content
OpenTrials
Completed

NCT Number: NCT01047592

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Changhua Hospital

Changhua, Taiwan, 513

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sarcosine

Drug

sarcosine, 2 g/d , oral, for 12 weeks

sarcosine+ BE

Drug

sarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks

Placebo

Drug

placebo,oral, for 12 weeks

Primary outcomes

  1. Positive, negative, cognitive symptoms of schizophrenia, laboratory tests.

    Time frame: 12 weeks

Secondary outcomes

  1. The subscales of PANSS,MATRICS, and serum DAAO levels.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Chang-Hua Hospital

Other Gov

Collaborators

  • China Medical University Hospital

Registry information

Official study title

N-methyl-D-aspartate (NMDA) Enhancers' Benefit to Schizophrenia Treatment

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 13, 2010
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.