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Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

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 2014 by Aviv Segev, Shalvata Mental Health Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01754532
First Posted: December 21, 2012
Last Update Posted: November 19, 2014
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 (Responsible Party):
Aviv Segev, Shalvata Mental Health Center
  Purpose

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 Intervention
Schizophrenia Schizo-Affective Disorder Biological: Hair Sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Aviv Segev, Shalvata Mental Health Center:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.

  • 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

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Schizophrenia patients Biological: Hair Sample
Analysis of hair cortisol levels

  Eligibility

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.


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/
  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): NCT01754532


Contacts
Contact: Aviv Segev, MD +972-9-7478644 aviv.segev@clalit.org.il
Contact: Yuval Bloch, MD +972-9-7478510 yuvalbl@clalit.org.il

Locations
Israel
Shalvata MHC Recruiting
Hod Hasharon, Israel
Contact: Aviv Segev, MD    +972-9-7874644    aviv.segev@clalit.org.il   
Principal Investigator: Aviv Segev, MD         
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: Aviv Segev, MD Shalvata MHC
  More Information

Responsible Party: Aviv Segev, Resident, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01754532     History of Changes
Other Study ID Numbers: SHA-12-0028
First Submitted: December 12, 2012
First Posted: December 21, 2012
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Aviv Segev, Shalvata Mental Health Center:
Schizophrenia
Schizo-Affective Disorder
Stress
Cortisol
PANSS

Additional relevant MeSH terms:
Schizophrenia
Mood Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents