ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
Stanley Medical Research Institute
Information provided by:
Sheba Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


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

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00138775


Contacts
Contact: Mark Weiser, MD ++972-352-6666575 mweiser@netvision.net.il

Locations
Israel
Ha-Emek Medical Center Not yet recruiting
Afula, Israel
Contact: Ilana Kremer, MD    ++972-46494350    kremer@aviv-pcb.com   
Principal Investigator: Ilana Kremer, MD         
Mazra Mental Health Center Recruiting
Akko, Israel
Contact: David Liba, MD    ++972-49559644    dliba1@netvision.net.il   
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    byabramovitch@beer-ness.health.gov.il   
Principal Investigator: Yehuda Abramovitch, MD         
Shalvata Mental Health Center Recruiting
Hod Hasharon, Israel
Contact: Yehiel Levkovitch, MD    ++972-97478568    ylev@clalit.org.il   
Principal Investigator: Yehiel Levkovitch, MD         
Kfar Shaul Psychiatric Hospital Recruiting
Jerusalem, Israel
Contact: Alexander Teitelbaum, MD    ++972-26448780    teital@barak-online.net   
Principal Investigator: Alexander Teitelbaum, MD         
The Sarah Herzog Memorial Hospital Recruiting
Jerusalem, Israel
Contact: Uriel Heresco-Levy, MD    ++972-25316906    heresco@md2.huji.ac.il   
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    drudinski@lev-hasaron.co.il   
Principal Investigator: Dimitri Rudinski, MD         
Geha Mental Health Center Recruiting
Petah Tiqwa, Israel
Contact: Shai Konas, MD    ++972-50-7215226    konass@clalit.org.il   
Principal Investigator: Shai Konas, MD         
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Mark Weiser, MD    ++972-52-6666576    mweiser@netvision.net.il   
Principal Investigator: Mark Weiser, MD         
Shaar Menashe Mental Health Center Not yet recruiting
Shaar Menashe, Israel
Contact: Shmuel Hirschmann, MD       hirscmann@shaar-menashe.org.il   
Principal Investigator: Shmuel Hirschman, MD         
Jaffa Mental Health Center Recruiting
Tel Aviv, Israel
Contact: Yosef Zimerman, MD    ++972-35151117    zimermanj@yahoo.com   
Principal Investigator: Yosef Zimerman, MD         
Maccabi Mental Health Center Not yet recruiting
Tel Aviv, Israel
Contact: Yerechmiel Barber, MD    ++972-35122196    ybarber@hotmail.co.il   
Principal Investigator: Yerechmiel Barber, MD         
Sponsors and Collaborators
Sheba Medical Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Mark Weiser, MD Sheba Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00138775     History of Changes
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:
D-serine
Negative symptoms
Cognition
Schizophrenia
Amino acid

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders