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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Shalvata Mental Health Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789022
First Posted: November 11, 2008
Last Update Posted: November 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shalvata Mental Health Center
  Purpose

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
Schizophrenia Schizophreniform Schizoaffective Disorder Brief Psychotic Episode

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Glycine and D-Serine levels in the plasma. [ Time Frame: 6-8 weeks ]

Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
40 subjects in a First Psychotic Episode
2
20 First Degree relatives
3
20 Healthy subjects

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients First degree ralatives Healthy subjects from the community
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789022


Contacts
Contact: Uri Nitzan, Md 00-972-9-7478532 urini@clalit.org.il
Contact: Uriel Levi-Herscho, MD 00-972-2-5316906 uriel heresco-levy [urielh@ekmd.huji.ac.il]

Locations
Israel
Shalvata Medical Center Active, not recruiting
Hod Hasharom, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
  More Information

Responsible Party: Dr. Uri Nitzan, Resident
ClinicalTrials.gov Identifier: NCT00789022     History of Changes
Other Study ID Numbers: uriel111
First Submitted: November 9, 2008
First Posted: November 11, 2008
Last Update Posted: November 11, 2008
Last Verified: November 2008

Keywords provided by Shalvata Mental Health Center:
First-Psychotic-Episode (FPE)
Glutamatergic system
Glycine
D-Serine
Oxytocin
Estrogen

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs