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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
History of Changes
  Purpose

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
Schizophrenia
Schizoaffective Disorder
 Drug: D-serine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Serine
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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            
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            
Jaffa Mental Health Center Recruiting
Tel Aviv, Israel
Contact: Yosef Zimerman, MD     ++972-35151117     zimermanj@yahoo.com    
Principal Investigator: Yosef Zimerman, MD            
Sponsors and Collaborators
Sheba Medical Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Mark Weiser, MD Sheba Medical Center
  More Information

No publications provided by Sheba Medical Center

Additional 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
Study First Received: August 28, 2005
Last Updated: December 24, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
D-serine
Negative symptoms
Cognition
Schizophrenia
Amino acid

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013