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

December 24, 2006 updated by: Sheba Medical Center

D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Afula, Israel
        • Not yet recruiting
        • Ha-Emek Medical Center
        • Contact:
        • Principal Investigator:
          • Ilana Kremer, MD
      • Akko, Israel
        • Recruiting
        • Mazra Mental Health Center
        • Contact:
        • Principal Investigator:
          • David Liba, MD
      • Bat Yam, Israel
        • Recruiting
        • Abarbanel Mental Health Center
        • Contact:
          • Motti Mashiah, MD
          • Phone Number: ++972-35552604
        • Principal Investigator:
          • Motti Mashiah, MD
      • Beer-Yaacov, Israel
        • Recruiting
        • Beer-Yaacov Mental Health Center
        • Contact:
        • Principal Investigator:
          • Yehuda Abramovitch, MD
      • Hod Hasharon, Israel
        • Recruiting
        • Shalvata Mental health Center
        • Contact:
        • Principal Investigator:
          • Yehiel Levkovitch, MD
      • Jerusalem, Israel
        • Recruiting
        • Kfar Shaul Psychiatric Hospital
        • Contact:
        • Principal Investigator:
          • Alexander Teitelbaum, MD
      • Jerusalem, Israel
        • Recruiting
        • The Sarah Herzog Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Uriel Heresco-L
      • Nes Ziona, Israel
        • Recruiting
        • Nes-Ziona Mental Health Center
        • Contact:
          • Daniela Amital, MD
          • Phone Number: ++972-50-8647067
        • Principal Investigator:
          • Daniela Amital, MD
      • Pardesiyya, Israel
        • Recruiting
        • Lev Hasharon Mental Health Center
        • Contact:
        • Principal Investigator:
          • Dimitri Rudinski, MD
      • Petah Tiqwa, Israel
        • Recruiting
        • Geha Mental Health Center
        • Contact:
        • Principal Investigator:
          • Shai Konas, MD
      • Ramat-Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Mark Weiser, MD
        • Contact:
      • Shaar Menashe, Israel
        • Not yet recruiting
        • Shaar Menashe Mental Health Center
        • Contact:
        • Principal Investigator:
          • Shmuel Hirschman, MD
      • Tel Aviv, Israel
        • Recruiting
        • Jaffa Mental Health Center
        • Contact:
        • Principal Investigator:
          • Yosef Zimerman, MD
      • Tel Aviv, Israel
        • Not yet recruiting
        • Maccabi Mental Health Center
        • Contact:
        • Principal Investigator:
          • Yerechmiel Barber, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Stanley Medical Research Institute

Investigators

  • Principal Investigator: Mark Weiser, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion

October 1, 2007

Study Registration Dates

First Submitted

August 28, 2005

First Submitted That Met QC Criteria

August 28, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

December 27, 2006

Last Update Submitted That Met QC Criteria

December 24, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-03-3093-MW-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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