Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Shalvata Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Aviv Segev, Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01754532
First received: December 12, 2012
Last updated: December 18, 2012
Last verified: December 2012
  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 Shalvata Mental Health Center:

Primary Outcome Measures:
  • Change from Baseline in Positive And Negative Symptoms Score [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Schizophrenia patients Biological: Hair Sample
Analysis of hair cortisol levels

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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

No publications provided

Responsible Party: Aviv Segev, Resident, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01754532     History of Changes
Other Study ID Numbers: SHA-12-0028
Study First Received: December 12, 2012
Last Updated: December 18, 2012
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Mood Disorders
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014