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Trial record 1 of 1 for:    NCT00138775
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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. 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
Stanley Medical Research Institute
Information provided by:
Sheba Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: D-serine Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia
Study Start Date : October 2004
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Serine

Primary Outcome Measures :
  1. SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
  2. Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16

Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16
  2. Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16
  3. Clinical Global Impressions (CGI) score - weeks 0, 8 and 16
  4. Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16
  5. Side effect check list

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT00138775

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Contact: Mark Weiser, MD ++972-352-6666575

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Ha-Emek Medical Center Not yet recruiting
Afula, Israel
Contact: Ilana Kremer, MD    ++972-46494350   
Principal Investigator: Ilana Kremer, MD         
Mazra Mental Health Center Recruiting
Akko, Israel
Contact: David Liba, MD    ++972-49559644   
Principal Investigator: David Liba, MD         
Abarbanel Mental Health Center Recruiting
Bat Yam, Israel
Contact: Motti Mashiah, MD    ++972-35552604      
Principal Investigator: Motti Mashiah, MD         
Beer-Yaacov Mental Health Center Recruiting
Beer-Yaacov, Israel
Contact: Yehuda Abramovitch, MD    ++972-89258221   
Principal Investigator: Yehuda Abramovitch, MD         
Shalvata Mental Health Center Recruiting
Hod Hasharon, Israel
Contact: Yehiel Levkovitch, MD    ++972-97478568   
Principal Investigator: Yehiel Levkovitch, MD         
Kfar Shaul Psychiatric Hospital Recruiting
Jerusalem, Israel
Contact: Alexander Teitelbaum, MD    ++972-26448780   
Principal Investigator: Alexander Teitelbaum, MD         
The Sarah Herzog Memorial Hospital Recruiting
Jerusalem, Israel
Contact: Uriel Heresco-Levy, MD    ++972-25316906   
Principal Investigator: Uriel Heresco-L         
Nes-Ziona Mental Health Center Recruiting
Nes Ziona, Israel
Contact: Daniela Amital, MD    ++972-50-8647067      
Principal Investigator: Daniela Amital, MD         
Lev Hasharon Mental Health Center Recruiting
Pardesiyya, Israel
Contact: Dimitri Rudinski, MD    ++972-98981210   
Principal Investigator: Dimitri Rudinski, MD         
Geha Mental Health Center Recruiting
Petah Tiqwa, Israel
Contact: Shai Konas, MD    ++972-50-7215226   
Principal Investigator: Shai Konas, MD         
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Mark Weiser, MD    ++972-52-6666576   
Principal Investigator: Mark Weiser, MD         
Shaar Menashe Mental Health Center Not yet recruiting
Shaar Menashe, Israel
Contact: Shmuel Hirschmann, MD   
Principal Investigator: Shmuel Hirschman, MD         
Jaffa Mental Health Center Recruiting
Tel Aviv, Israel
Contact: Yosef Zimerman, MD    ++972-35151117   
Principal Investigator: Yosef Zimerman, MD         
Maccabi Mental Health Center Not yet recruiting
Tel Aviv, Israel
Contact: Yerechmiel Barber, MD    ++972-35122196   
Principal Investigator: Yerechmiel Barber, MD         
Sponsors and Collaborators
Sheba Medical Center
Stanley Medical Research Institute
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Principal Investigator: Mark Weiser, MD Sheba Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00138775    
Other Study ID Numbers: SHEBA-03-3093-MW-CTIL
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: December 27, 2006
Last Verified: October 2006
Keywords provided by Sheba Medical Center:
Negative symptoms
Amino acid
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders