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D-Serine Monotherapy for Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by Herzog Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: September 22, 2005
Last Update Posted: May 3, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Herzog Hospital

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 Intervention Phase
Schizophrenia Drug: D-serine 2100 mg daily Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Herzog Hospital:

Estimated Enrollment: 40

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.
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00215917     History of Changes
Other Study ID Numbers: lichtenberg1CTIL
First Submitted: September 18, 2005
First Posted: September 22, 2005
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