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

NCT01047592 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-07-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • China Medical University Hospital

    collaborator OTHER

  • Chang-Hua Hospital

    lead OTHER_GOV

Principal Investigators

  • Chun-yuan Lin, MD · Changhua Hospital

  • Hsien-yuan Lane, MD,PHD · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01047592 on ClinicalTrials.gov