Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

April 18, 2018 updated by: Aviv Segev, Shalvata Mental Health Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hod Hasharon, Israel
        • Shalvata MHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Schizophrenia or Schizo-Affective Disorder

Description

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/

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 month
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.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 month
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shalvata Mental Health Center

Investigators

  • Principal Investigator: Aviv Segev, MD, Shalvata MHC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 18, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHA-12-0028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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