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D-Serine Monotherapy for Schizophrenia

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ClinicalTrials.gov Identifier: NCT00215917
Recruitment Status : Unknown
Verified May 2006 by Herzog Hospital.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : May 3, 2006
Information provided by:
Herzog Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: D-serine 2100 mg daily Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Serine
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. DSM-IV criteria for chronic schizophrenia
  2. Treatment resistant
  3. aged 18-70
  4. Two months on stable risperidone dose
  5. PANSS positive symptom cluster score >20
  6. PANSS negative symptom cluster score >22

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215917

Contact: Pesach Lichtenberg, M.D. 972-2-6221154 licht@cc.huji.ac.il

Herzog Hospital, Department of Psychiatry Recruiting
Jerusalem, Israel, 91351
Contact: Pesach Lichtenberg, M.D.    972-2-5316929    licht@cc.huji.ac.il   
Sponsors and Collaborators
Herzog Hospital
Principal Investigator: Pesach Lichtenberg, M.D. Herzog Hospital, and Hadassah Medical School--the Hebrew University of Jerusalem, Israel

ClinicalTrials.gov Identifier: NCT00215917     History of Changes
Other Study ID Numbers: lichtenberg1CTIL
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: May 2006

Keywords provided by Herzog Hospital:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders