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

November 10, 2008 updated by: Shalvata Mental Health Center

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

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

Study Locations

Israel
- - Hod Hasharom, Israel
    - Shalvata Medical Center

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients First degree ralatives Healthy subjects from the community

Description

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

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 40 subjects in a First Psychotic Episode
2 20 First Degree relatives
3 20 Healthy subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycine and D-Serine levels in the plasma. Time Frame: 6-8 weeks	6-8 weeks

Collaborators and Investigators

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

Sponsor

Shalvata Mental Health Center

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

January 1, 2009

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

November 9, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)