- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01754532
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Hod Hasharon, Israel
- Shalvata MHC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Schizophrenia patients
|
Analysis of hair cortisol levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 month
|
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.
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 month
|
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.
|
6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aviv Segev, MD, Shalvata MHC
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHA-12-0028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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