Ignite Creation Date:
2024-05-06 @ 2:06 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01975584
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2013-10-18
Brief Title:
Neuroendocrine and Immune Response to Stress in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Neuroendocrine and Immune Response to Stress in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TSST
Brief Summary:
This is a pilot study We are testing the physiologic immune and chemical responses to stress We believe the results of all measures to stress will be blunted in schizophrenia compared to healthy controls We will test sex early life stress and other factors on the relationship to a stress response
Detailed Description:
The proposed study examines the response of neuroimmune and inflammatory responses to a stress in both men and women with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder The measurements include stress hormones or other elements in the blood which indicate stress Early childhood traumastress ELS information will be collected so we can examine differences in those with trauma histories vs those with none by sex There will be one visit for screening before the testing visit The sample will consist of up to 45 clinically stable inpatients and outpatients with DSM-IV schizophrenia or schizoaffective disorder of which approximately 15 will be women We will also enroll up to 45 healthy controls without a DSM-IV Axis I or II disorder Prior to the study all subjects must meet inclusion and exclusion criteria including a medical history
The TSST is a standard and widely used research assessment procedure that is used to reliably induce stress in human research participants The TSST uses situations where people think they are being socially evaluated during an interview for a job Participants are told they are competing with other people for this job and their task is to convince interviewers that they are the best person for the job Participants are told they have to prepare a speech and complete a math challenge in their head
The TSST is a standard and widely used research assessment procedure that is used to reliably induce stress in human research participants The TSST uses situations where people think they are being socially evaluated during an interview for a job Participants are told they are competing with other people for this job and their task is to convince interviewers that they are the best person for the job Participants are told they have to prepare a speech and complete a math challenge in their head
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None