Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

NCT01754532 | Completed

• 1 other identifier: SHA-12-0028
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizo-Affective Disorder

Keywords

Schizophrenia; Schizo-Affective Disorder; Stress; Cortisol; PANSS

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores

  3 month

• Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores

  6 month

Study Arms (1)

Schizophrenia patients

Biological: Hair Sample

Interventions

Hair Sample BIOLOGICAL

Analysis of hair cortisol levels

Schizophrenia patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Schizophrenia or Schizo-Affective Disorder

You may qualify if:

• Age 18-50
• Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist.
• Signing an informed consent.

You may not qualify if:

• 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/

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata MHC

Hod HaSharon, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

10mg of posterior vertex hair

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Aviv Segev, MD

  Shalvata MHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 21, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

IL (1)