Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

NCT ID: NCT01754532

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizo-Affective Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Schizophrenia patients

Hair Sample

Intervention Type BIOLOGICAL

Analysis of hair cortisol levels

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hair Sample

Analysis of hair cortisol levels

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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/
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aviv Segev

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aviv Segev, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata MHC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shalvata MHC

Hod HaSharon, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHA-12-0028

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vitamin D for Schizophrenia
NCT01759485 COMPLETED NA
Trial of D-Cycloserine in Schizophrenia
NCT00000371 COMPLETED PHASE3