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Israel Multicenter D-Serine Study (IMSER) for the Treatment of 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 October 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
Stanley Medical Research Institute
Information provided by:
Sheba Medical Center Identifier:
First received: August 28, 2005
Last updated: December 24, 2006
Last verified: October 2006

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.

Condition Intervention Phase
Schizoaffective Disorder
Drug: D-serine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: October 2004
Estimated Study Completion Date: October 2007

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00138775

Ha-Emek Medical Center
Afula, Israel
Mazra Mental Health Center
Akko, Israel
Abarbanel Mental Health Center
Bat Yam, Israel
Beer-Yaacov Mental Health Center
Beer-Yaacov, Israel
Shalvata Mental Health Center
Hod Hasharon, Israel
Kfar Shaul Psychiatric Hospital
Jerusalem, Israel
The Sarah Herzog Memorial Hospital
Jerusalem, Israel
Nes-Ziona Mental Health Center
Nes Ziona, Israel
Lev Hasharon Mental Health Center
Pardesiyya, Israel
Geha Mental Health Center
Petah Tiqwa, Israel
Sheba Medical Center
Ramat-Gan, Israel
Shaar Menashe Mental Health Center
Shaar Menashe, Israel
Jaffa Mental Health Center
Tel Aviv, Israel
Maccabi Mental Health Center
Tel Aviv, Israel
Sponsors and Collaborators
Sheba Medical Center
Stanley Medical Research Institute
Principal Investigator: Mark Weiser, MD Sheba Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00138775     History of Changes
Other Study ID Numbers: SHEBA-03-3093-MW-CTIL 
Study First Received: August 28, 2005
Last Updated: December 24, 2006

Keywords provided by Sheba Medical Center:
Negative symptoms
Amino acid

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on February 17, 2017