Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

Completed

• Conditions: Schizo-Affective Disorder; Schizophrenia
• Interventions: Biological: Hair Sample

• Registration Number: NCT01754532
• Lead Sponsor: Shalvata Mental Health Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Study Start: 2013-01
• Primary Completion: 2015-06
• Study Completion: 2016-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Schizophrenia patients	Hair Sample	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Positive And Negative Symptoms Score	6 month	correlation between hair cortisol level change from baseline and PANSS score change from baseline.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores	6 month	correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline.

Trial Locations

Locations (1)

Shalvata MHC; 🇮🇱 Hod Hasharon, Israel