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Israel Multicenter D-Serine Study (IMSER) for the Treatment of Schizophrenia

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.
ClinicalTrials.gov Identifier: NCT00138775
Recruitment Status : Unknown
Verified October 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : August 30, 2005
Last Update Posted : December 27, 2006
Sponsor:
Collaborator:
Information provided by:

August 28, 2005
August 30, 2005
December 27, 2006
October 2004
Not Provided
  • SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
  • Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16
  • SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
  • MATRICS battery - visits week 0, 8 and 16.
Complete list of historical versions of study NCT00138775 on ClinicalTrials.gov Archive Site
  • Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16
  • Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16
  • Clinical Global Impressions (CGI) score - weeks 0, 8 and 16
  • Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16
  • Side effect check list
  • PANSS positive, negative, general and total score - weeks 0, 8 and 16.
  • SAS total score - weeks 0, 8 and 16.
  • CGI score - weeks 0, 8 and 16.
  • CDSS score - weeks 0, 8 and 16
  • Side effect check list
Not Provided
Not Provided
 
Israel Multicenter D-Serine Study (IMSER) for the Treatment of Schizophrenia
D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia

The goal of the present study is to evaluate the effect of D-serine, added to antipsychotic treatment, on negative and cognitive symptoms in schizophrenia.

The investigators are hypothesizing that D-serine will improve cognitive functioning and negative symptoms.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
Drug: D-serine
Not Provided
Weiser M, Heresco-Levy U, Davidson M, Javitt DC, Werbeloff N, Gershon AA, Abramovich Y, Amital D, Doron A, Konas S, Levkovitz Y, Liba D, Teitelbaum A, Mashiach M, Zimmerman Y. A multicenter, add-on randomized controlled trial of low-dose d-serine for negative and cognitive symptoms of schizophrenia. J Clin Psychiatry. 2012 Jun;73(6):e728-34. doi: 10.4088/JCP.11m07031.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
October 2007
Not Provided

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) diagnosis of schizophrenia and\or schizoaffective disorder.
  • Age between 18 to 64.
  • PANSS negative symptom score higher than 19.
  • SAS total score lower than 12.
  • CDSS suicidal risk lower than 2

Exclusion Criteria:

  • Epilepsy
  • Meets DSM-IV criteria for mental retardation.
  • Medical condition which confounds presentation or treatment (e.g. uncontrolled diabetes mellitus, history of kidney stones, acute drug toxicity, dementia, delirium, stroke, etc.)
  • Meets DSM-IV criteria for alcohol or drug dependence in last 6 months.
  • Meets DSM-IV criteria for alcohol or drug abuse in last one month.
  • Treatment with clozapine.
  • Current positive pregnancy test or not using acceptable method of birth control.
  • Meets DSM-IV criteria for current anxiety or mood disorders
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00138775
SHEBA-03-3093-MW-CTIL
Not Provided
Not Provided
Not Provided
Not Provided
Sheba Medical Center
Stanley Medical Research Institute
Principal Investigator: Mark Weiser, MD Sheba Medical Center
Sheba Medical Center
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP