SchizophreniaNCT01754532
Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels
An observational study of Schizophrenia and Schizo-Affective Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Schizo-Affective Disorder
- What is being tested?
- Hair Sample
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients diagnosed with Schizophrenia or Schizo-Affective Disorder
Who may be able to join
- Age 18-50
- Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist.
- Signing an informed consent.
Who cannot join
- 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/
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Hair Sample
- Keywords
- Schizophrenia, Schizo-Affective Disorder, Stress, Cortisol, PANSS
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair SampleBiological
Analysis of hair cortisol levels
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia patients | Not described Receives: Biological: Hair Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Positive And Negative Symptoms Score
correlation between hair cortisol level change from baseline and PANSS score change from baseline.
Measured: 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.
Measured: 6 month
Secondary outcomes (2)
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.
Measured: 3 month
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aviv Segev, Shalvata Mental Health Center
- Investigators
- Aviv Segev, MD, Principal investigator, Shalvata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754532
- Sponsor's protocol ID
- SHA-12-0028
- Status last verified
- Apr 2018
- First submitted
- 12 Dec 2012
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels
- ClinicalTrials.gov ID
- NCT01754532
- Acronym / sponsor ID
- SHA-12-0028
- Conditions
- Schizophrenia, Schizo-Affective Disorder
- Keywords
- Schizophrenia, Schizo-Affective Disorder, Stress, Cortisol, PANSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia patients | – | Biological: Hair Sample |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with Schizophrenia or Schizo-Affective Disorder
Key inclusion criteria (3 listed)
- Age 18-50
- Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist.
- Signing an informed consent.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair SampleAnalysis of hair cortisol levels | Biological | Schizophrenia patients |
Primary outcome
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.
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.
2 secondary outcomes
Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores
Time frame: 3 month
Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aviv Segev, MD principal investigator
Shalvata MHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizo-Affective Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Positive And Negative Symptoms Score (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.