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

This study has been completed.
Sponsor:
Collaborator:
China Medical University Hospital
Information provided by (Responsible Party):
Chun Yuan Lin , MD, Chang-Hua Hospital
ClinicalTrials.gov Identifier:
NCT01047592
First received: January 12, 2010
Last updated: July 6, 2014
Last verified: July 2014

January 12, 2010
July 6, 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 ] [ Designated as safety issue: Yes ]
Positive, negative, cognitive symptoms of schizophrenia, metabolic syndrome parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01047592 on ClinicalTrials.gov Archive Site
The subscales of PANSS,MATRICS, and serum DAAO levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
The subscales of PANSS and SANS [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01047592
DMR98-IR-014, HAC9814
Yes
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