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D-Serine Monotherapy for Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Herzog Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Herzog Hospital
ClinicalTrials.gov Identifier:
NCT00215917
First received: September 18, 2005
Last updated: May 1, 2006
Last verified: May 2006
History of Changes
  Purpose

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-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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

Further study details as provided by Herzog Hospital:

Estimated Enrollment: 40
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215917

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

Locations
Israel
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
Investigators
Principal Investigator: Pesach Lichtenberg, M.D. Herzog Hospital, and Hadassah Medical School--the Hebrew University of Jerusalem, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00215917     History of Changes
Other Study ID Numbers: lichtenberg1CTIL
Study First Received: September 18, 2005
Last Updated: May 1, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Herzog Hospital:
Schizophrenia
NMDA
D-serine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013