NCT00491569

Brief Summary

Both GlyT-1 inhibitors and NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia patients. The purpose of this study is to compare efficacy and safety of add-on treatment of sarcosine, a GlyT-1 inhibitor, and D-serine, an NMDA-glycine site agonist, in chronically stable schizophrenia patients who have been stabilized with antipsychotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

June 26, 2007

Status Verified

June 1, 2007

First QC Date

June 24, 2007

Last Update Submit

June 24, 2007

Conditions

SchizophreniasPsychosesPsychotic DisordersSchizophrenic Disorders

Keywords

SchizophreniasarcosineD-serineNMDA

Outcome Measures

Primary Outcomes (1)

  • Total scores of Positive and Negative Syndrome Scale (PANSS) and Quality of Life (QOL)

    6 weeks

Secondary Outcomes (1)

  • Subscales of PANSS

    6 weeks

Interventions

Sarcosine and D-serineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
  • Agree to participate in the study and provide informed consent.

You may not qualify if:

  • Meet DSM-IV criteria of major mood disorder, current substance dependence or mental retardation
  • History of epilepsy, head trauma or CNS diseases
  • Major, untreated medical diseases
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (2)

  • Lane HY, Chang YC, Liu YC, Chiu CC, Tsai GE. Sarcosine or D-serine add-on treatment for acute exacerbation of schizophrenia: a randomized, double-blind, placebo-controlled study. Arch Gen Psychiatry. 2005 Nov;62(11):1196-204. doi: 10.1001/archpsyc.62.11.1196.

    PMID: 16275807BACKGROUND

  • Lane HY, Lin CH, Huang YJ, Liao CH, Chang YC, Tsai GE. A randomized, double-blind, placebo-controlled comparison study of sarcosine (N-methylglycine) and D-serine add-on treatment for schizophrenia. Int J Neuropsychopharmacol. 2010 May;13(4):451-60. doi: 10.1017/S1461145709990939. Epub 2009 Nov 4.

    PMID: 19887019DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Sarcosine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

N-substituted GlycinesGlycineAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Hsien-Yuan Lane, MD,PhD

    Department of Psychiatry, China Medical University Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2007

First Posted

June 26, 2007

Study Start

January 1, 2005

Study Completion

December 1, 2006

Last Updated

June 26, 2007

Record last verified: 2007-06

Locations

TW(1)