Glutamatergic Amino Acids and Oxytocin Levels in the Plasma of Patients in First Psychotic Episode (FPE)- Before and After Neuroleptic Treatment

Sponsor
Shalvata Mental Health Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00789022
Collaborator
(none)
80
1

Study Details

Study Description

Brief Summary

The goal of our research is to check the levels of D-Serine, Glycine, and other Glutamatergic amino acids, in patients with First Psychotic Episode (FPE). These patients are in the early stage of the disease, treated with neuroleptics for short periods of time, and are usually hospitalized for the first time. The hypothesis of the research is that we will find low levels of Glycine and D-Serine in these patients. Following an Anti-psychotic treatment we will expect these levels to return to the norm, and that this correction will be accompanied by a reduction of positive and negative symptoms.

In addition, we will check the D-Serine and Glycine levels in the plasma of first degree relatives of the patients and a group of healthy subjects. The results of this study might support the hypothesis that the Glutamatergic system in involved in the pathology of Schizophrenia from it's early stages.

In addition, we will check the levels of Oxytocin and Estrogen in the plasma of patients in FPE. Our hypothesis is that we will find low levels of Estrogen and High levels of Oxytocin in this group of patients. The results of the study might support the hypothesis that Estrogen and Oxytocin are involved in the pathology of Schizophrenia from it's early stages.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Time Perspective:
    Prospective
    Study Start Date :
    Jan 1, 2009
    Anticipated Primary Completion Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    40 subjects in a First Psychotic Episode

    2

    20 First Degree relatives

    3

    20 Healthy subjects

    Outcome Measures

    Primary Outcome Measures

    1. Glycine and D-Serine levels in the plasma. [6-8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Subjects between 18-60 years

    • Clinical Diagnosis of Schizophrenia, Schizophreniphorm disorder, Schizoaffective Disorder, Brief esychotic episode

    Exclusion Criteria:
    • two years or more of positive symptoms

    • Neuroleptic treatment for more then twe weeks in the prior month, or for more then six weeks at any time.

    • Drug induced psychotic episode

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shalvata Medical Center Hod Hasharom Israel

    Sponsors and Collaborators

    • Shalvata Mental Health Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00789022
    Other Study ID Numbers:
    • uriel111
    First Posted:
    Nov 11, 2008
    Last Update Posted:
    Nov 11, 2008
    Last Verified:
    Nov 1, 2008

    Study Results

    No Results Posted as of Nov 11, 2008