Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754532
• Other study ID #: SHA-12-0028
• Status: Completed
• First received: December 12, 2012
• Last updated: April 18, 2018
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: April 2018
• Source: Shalvata Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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/

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizo-Affective Disorder
• Schizophrenia

Intervention

Biological:
• Hair Sample
Analysis of hair cortisol levels

Locations

Country	Name	City	State
Israel	Shalvata MHC	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Positive And Negative Symptoms Score	correlation between hair cortisol level change from baseline and PANSS score change from baseline.	3 month
Primary	Change from Baseline in Positive And Negative Symptoms Score	correlation between hair cortisol level change from baseline and PANSS score change from baseline.	6 month
Secondary	Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores	correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline.	3 month
Secondary	Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores	correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline.	6 month