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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00789022
• Other study ID #: uriel111
• Status: Not yet recruiting
• Phase: N/A
• First received: November 9, 2008
• Last updated: November 10, 2008
• Start date: January 2009

Study information

• Verified date: November 2008
• Source: Shalvata Mental Health Center
• Contact: Uri Nitzan, Md
• Phone: 00-972-9-7478532
• Email: urini[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Brief Psychotic Episode
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform

Locations

Country	Name	City	State
Israel	Shalvata Medical Center	Hod Hasharom

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycine and D-Serine levels in the plasma.		6-8 weeks	No