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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00138775
First received: August 28, 2005
Last updated: December 24, 2006
Last verified: October 2006

August 28, 2005
December 24, 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
 
Recruiting
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
Both
18 Years to 64 Years
No
Contact: Mark Weiser, MD ++972-352-6666575 mweiser@netvision.net.il
Israel
 
NCT00138775
SHEBA-03-3093-MW-CTIL
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