Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizo-Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shalvata MHC

Hod HaSharon, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/

Treatment and study plan

Hair Sample

Biological

Analysis of hair cortisol levels

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Shalvata Mental Health Center

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Dec 21, 2012
Registry last updated: Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed