NCT00215917

Brief Summary

N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic medication, has reduced negative, depressive, and cognitive symptomatology. We will be investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as monotherapy for treatment resistant schizophrenics. 40 subjects on stable doses of risperidone will be randomized under double-blind conditions into a treatment group, which will receive D-serine 2100 mg, or a control group, which will continue to receive risperidone. Treatment will continue for 14 weeks. Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and UKU. Before and after the trial subjects will undergo neuropsychological assessments. Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed. The primary outcome measures of the study will be the PANSS total scores and the positive and negative symptom cluster scores.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

May 3, 2006

Status Verified

May 1, 2006

First QC Date

September 18, 2005

Last Update Submit

May 1, 2006

Conditions

Schizophrenia

Keywords

SchizophreniaNMDAD-serine

Interventions

D-serine 2100 mg dailyDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV criteria for chronic schizophrenia
  • Treatment resistant
  • aged 18-70
  • Two months on stable risperidone dose
  • PANSS positive symptom cluster score \>20
  • PANSS negative symptom cluster score \>22

You may not qualify if:

  • Substance abuse
  • Concurrent DSM IV axis I disorder
  • Serious medical disorder
  • Concurrent drug therapy that can obscure the effect of risperidone or DSR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzog Hospital, Department of Psychiatry

Jerusalem, 91351, Israel

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Pesach Lichtenberg, M.D.

    Herzog Hospital, and Hadassah Medical School--the Hebrew University of Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pesach Lichtenberg, M.D.

CONTACT

972-2-6221154licht@cc.huji.ac.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2005

First Posted

September 22, 2005

Last Updated

May 3, 2006

Record last verified: 2006-05

Locations

IL(1)