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Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

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.
 
ClinicalTrials.gov Identifier: NCT01754532
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Aviv Segev, Shalvata Mental Health Center

Brief Summary:

The importance of stress as a possible deteriorating factor for schizophrenic patients is well documented. However, this notion is based on subjective experience and retrospective psychological analysis.

A novel method of measuring cortisol using hair has a proven correlation to subjective stress in non-clinical as well as psychiatric clinical populations.

This pilot study will attempt to assess the use of cortisol hair level, as a marker of stress, to predict clinical deterioration in schizophrenic patients.


Condition or disease Intervention/treatment
Schizophrenia Schizo-Affective Disorder Biological: Hair Sample

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
Schizophrenia patients Biological: Hair Sample
Analysis of hair cortisol levels




Primary Outcome Measures :
  1. Change from Baseline in Positive And Negative Symptoms Score [ Time Frame: 3 month ]
    correlation between hair cortisol level change from baseline and PANSS score change from baseline.

  2. Change from Baseline in Positive And Negative Symptoms Score [ Time Frame: 6 month ]
    correlation between hair cortisol level change from baseline and PANSS score change from baseline.


Secondary Outcome Measures :
  1. Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores [ Time Frame: 3 month ]
    correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline.

  2. Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores [ Time Frame: 6 month ]
    correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline.


Biospecimen Retention:   Samples Without DNA
10mg of posterior vertex hair


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Schizophrenia or Schizo-Affective Disorder
Criteria

Inclusion Criteria:

  • Age 18-50
  • Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist.
  • Signing an informed consent.

Exclusion Criteria:

  • Additional psychiatric diagnosis
  • Boldness or hair shorter than 1cm
  • Physiological disturbance in the HPA or the use of steroidal medication
  • Neurological disease (past or present) or neurosurgery.
  • Pregnancy
  • Substantial chronic physical diseases/

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): NCT01754532


Locations
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Israel
Shalvata MHC
Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
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Principal Investigator: Aviv Segev, MD Shalvata MHC
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Responsible Party: Aviv Segev, Resident, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01754532    
Other Study ID Numbers: SHA-12-0028
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Keywords provided by Aviv Segev, Shalvata Mental Health Center:
Schizophrenia
Schizo-Affective Disorder
Stress
Cortisol
PANSS
Additional relevant MeSH terms:
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Schizophrenia
Mood Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders