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Clinical Trials/NCT01754532
NCT01754532
Completed
Not Applicable

Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

Shalvata Mental Health Center1 site in 1 country34 target enrollmentJanuary 2013
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ConditionsSchizophreniaSchizo-Affective Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Shalvata Mental Health Center
Enrollment
34
Locations
1
Primary Endpoint
Change from Baseline in Positive And Negative Symptoms Score
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
January 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aviv Segev

Resident

Shalvata Mental Health Center

Eligibility 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/

Outcomes

Primary Outcomes

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(6 month)

Study Sites (1)

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