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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
D-serine
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring D-serine, Negative symptoms, Cognition, Schizophrenia, Amino acid

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ha-Emek Medical Center
  • Mazra Mental Health CenterRecruiting
  • Abarbanel Mental Health CenterRecruiting
  • Beer-Yaacov Mental Health CenterRecruiting
  • Shalvata Mental Health CenterRecruiting
  • Kfar Shaul Psychiatric HospitalRecruiting
  • The Sarah Herzog Memorial HospitalRecruiting
  • Nes-Ziona Mental Health CenterRecruiting
  • Lev Hasharon Mental Health CenterRecruiting
  • Geha Mental Health CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Shaar Menashe Mental Health Center
  • Jaffa Mental Health CenterRecruiting
  • Maccabi Mental Health Center

Outcomes

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

Full Information

First Posted
August 28, 2005
Last Updated
December 24, 2006
Sponsor
Sheba Medical Center
Collaborators
Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00138775
Brief Title
Israel Multicenter D-Serine Study (IMSER) for the Treatment of Schizophrenia
Official Title
D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center
Collaborators
Stanley Medical Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
D-serine, Negative symptoms, Cognition, Schizophrenia, Amino acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
D-serine
Primary Outcome Measure Information:
Title
SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
Title
Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16
Title
Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16
Title
Clinical Global Impressions (CGI) score - weeks 0, 8 and 16
Title
Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16
Title
Side effect check list

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Weiser, MD
Phone
++972-352-6666575
Email
mweiser@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Weiser, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ha-Emek Medical Center
City
Afula
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Kremer, MD
Phone
++972-46494350
Email
kremer@aviv-pcb.com
First Name & Middle Initial & Last Name & Degree
Ilana Kremer, MD
Facility Name
Mazra Mental Health Center
City
Akko
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Liba, MD
Phone
++972-49559644
Email
dliba1@netvision.net.il
First Name & Middle Initial & Last Name & Degree
David Liba, MD
Facility Name
Abarbanel Mental Health Center
City
Bat Yam
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Motti Mashiah, MD
Phone
++972-35552604
First Name & Middle Initial & Last Name & Degree
Motti Mashiah, MD
Facility Name
Beer-Yaacov Mental Health Center
City
Beer-Yaacov
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yehuda Abramovitch, MD
Phone
++972-89258221
Email
byabramovitch@beer-ness.health.gov.il
First Name & Middle Initial & Last Name & Degree
Yehuda Abramovitch, MD
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yehiel Levkovitch, MD
Phone
++972-97478568
Email
ylev@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Yehiel Levkovitch, MD
Facility Name
Kfar Shaul Psychiatric Hospital
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Teitelbaum, MD
Phone
++972-26448780
Email
teital@barak-online.net
First Name & Middle Initial & Last Name & Degree
Alexander Teitelbaum, MD
Facility Name
The Sarah Herzog Memorial Hospital
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uriel Heresco-Levy, MD
Phone
++972-25316906
Email
heresco@md2.huji.ac.il
First Name & Middle Initial & Last Name & Degree
Uriel Heresco-L
Facility Name
Nes-Ziona Mental Health Center
City
Nes Ziona
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Amital, MD
Phone
++972-50-8647067
First Name & Middle Initial & Last Name & Degree
Daniela Amital, MD
Facility Name
Lev Hasharon Mental Health Center
City
Pardesiyya
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitri Rudinski, MD
Phone
++972-98981210
Email
drudinski@lev-hasaron.co.il
First Name & Middle Initial & Last Name & Degree
Dimitri Rudinski, MD
Facility Name
Geha Mental Health Center
City
Petah Tiqwa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shai Konas, MD
Phone
++972-50-7215226
Email
konass@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Shai Konas, MD
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Weiser, MD
Phone
++972-52-6666576
Email
mweiser@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Mark Weiser, MD
Facility Name
Shaar Menashe Mental Health Center
City
Shaar Menashe
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shmuel Hirschmann, MD
Email
hirscmann@shaar-menashe.org.il
First Name & Middle Initial & Last Name & Degree
Shmuel Hirschman, MD
Facility Name
Jaffa Mental Health Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yosef Zimerman, MD
Phone
++972-35151117
Email
zimermanj@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yosef Zimerman, MD
Facility Name
Maccabi Mental Health Center
City
Tel Aviv
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yerechmiel Barber, MD
Phone
++972-35122196
Email
ybarber@hotmail.co.il
First Name & Middle Initial & Last Name & Degree
Yerechmiel Barber, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22795211
Citation
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.
Results Reference
derived

Learn more about this trial

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

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