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

NCT01047592 | Completed Phase 2 DMC

• 2 other identifiers: DMR98-IR-014HAC9814
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; cognitive function; N-methyl-D-aspartate receptor

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (3)

sarcosine

ACTIVE COMPARATOR

Drug: sarcosine

sarcosine+ BE

ACTIVE COMPARATOR

Drug: sarcosine+ BE

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

sarcosine DRUG

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

sarcosine

sarcosine+ BE DRUG

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

sarcosine+ BE

placebo DRUG

placebo,oral, for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang-Hua Hospital: lead
• China Medical University Hospital: collaborator

Study Sites (1)

Changhua Hospital

Changhua, Taiwan, 513, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Sarcosine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

N-substituted Glycines; Glycine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Chun-yuan Lin, MD

  Changhua Hospital

  PRINCIPAL INVESTIGATOR

• Hsien-yuan Lane, MD,PHD

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

TW (1)