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
  Purpose

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 Intervention Phase
Schizophrenia
Drug: sarcosine
Drug: sarcosine+ BE
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-methyl-D-aspartate (NMDA) Enhancers' Benefit to Schizophrenia Treatment

Resource links provided by NLM:


Further study details as provided by Chang-Hua Hospital:

Primary Outcome Measures:
  • Positive, negative, cognitive symptoms of schizophrenia, laboratory tests. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The subscales of PANSS,MATRICS, and serum DAAO levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: March 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047592

Locations
Taiwan
Changhua Hospital
Changhua, Taiwan, 513
Sponsors and Collaborators
Chang-Hua Hospital
China Medical University Hospital
Investigators
Principal Investigator: Chun-yuan Lin, MD Changhua Hospital
Study Director: Hsien-yuan Lane, MD,PHD China Medical University Hospital
  More Information

No publications provided

Responsible Party: Chun Yuan Lin , MD, Attending, Chang-Hua Hospital
ClinicalTrials.gov Identifier: NCT01047592     History of Changes
Other Study ID Numbers: DMR98-IR-014, HAC9814
Study First Received: January 12, 2010
Last Updated: July 6, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Chang-Hua Hospital:
Schizophrenia
cognitive function
N-methyl-D-aspartate receptor

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014