NCT00789022

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

November 11, 2008

Status Verified

November 1, 2008

Enrollment Period

1.5 years

First QC Date

November 9, 2008

Last Update Submit

November 10, 2008

Conditions

Keywords

First-Psychotic-Episode (FPE)Glutamatergic systemGlycineD-SerineOxytocinEstrogen

Outcome Measures

Primary Outcomes (1)

  • Glycine and D-Serine levels in the plasma.

    6-8 weeks

Study Arms (3)

1

40 subjects in a First Psychotic Episode

2

20 First Degree relatives

3

20 Healthy subjects

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients First degree ralatives Healthy subjects from the community

You may qualify if:

  • Subjects between 18-60 years
  • Clinical Diagnosis of Schizophrenia, Schizophreniphorm disorder, Schizoaffective Disorder, Brief esychotic episode

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata Medical Center

Hod Hasharom, Israel

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2008

First Posted

November 11, 2008

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Last Updated

November 11, 2008

Record last verified: 2008-11

Locations