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Neuroendocrine and Immune Response to Stress in Schizophrenia (TSST)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trier Social Stress Test
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder (schizophrenia group)
  • No DSM-IV Axis I or II disorder (healthy control group)
  • Caucasian or Non-Caucasian

Exclusion Criteria:

  • History of Cushing's syndrome, adrenal deficiency, or any condition that may affect cortisol levels in the body.
  • Use of steroids
  • Pregnancy or lactation. Pregnancy will be determined by urine pregnancy test. Lactation will be determined through patient report.
  • Untreated hypertension, cardiac arrthymias or medical condition that could not handle stress.

Sites / Locations

  • Maryland Psychiatric Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trier Social Stress Test

Arm Description

Participants will participate in a standardized role play (Trier Social Stress Test ). A role play is pretending to be in a certain situation. A research staff member will describe the role play, during which teh participant will act out a scene. Participants will be asked to imagine that they are in a certain role with several other research team members who will also participate in the role play. Participants will also be asked to do some math problems without using paper or pencil.

Outcomes

Primary Outcome Measures

Aim 1) To examine neuroendocrine and physiologic response following a psychosocial stressor in people with schizophrenia and healthy controls.
We will administer the Trier Social Stress Test (TSST) and measure neuroendocrine values (plasma and salivary cortisol and adrenocorticotropic hormone (ACTH) and physiologic variables (heart rate, blood pressure) before during and after the TSST.

Secondary Outcome Measures

To investigate neuroimmune and kynurenic acid modulation to a psychosocial stressor in people with schizophrenia and healthy controls
We will measure peripheral cytokine response (IL-6, IL1-Beta, TNF alpha) and kynruenic acid, kynurenine and pathway metabolites before, during and after the TSST.

Full Information

First Posted
October 18, 2013
Last Updated
September 25, 2019
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT01975584
Brief Title
Neuroendocrine and Immune Response to Stress in Schizophrenia
Acronym
TSST
Official Title
Neuroendocrine and Immune Response to Stress in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 trauma/stress (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trier Social Stress Test
Arm Type
Experimental
Arm Description
Participants will participate in a standardized role play (Trier Social Stress Test ). A role play is pretending to be in a certain situation. A research staff member will describe the role play, during which teh participant will act out a scene. Participants will be asked to imagine that they are in a certain role with several other research team members who will also participate in the role play. Participants will also be asked to do some math problems without using paper or pencil.
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Test
Intervention Description
Participants will participate in a standardized role play (Trier Social Stress Test ). A role play is pretending to be in a certain situation. A research staff member will describe the role play, during which teh participant will act out a scene. Participants will be asked to imagine that they are in a certain role with several other research team members who will also participate in the role play. Participants will also be asked to do some math problems without using paper or pencil.
Primary Outcome Measure Information:
Title
Aim 1) To examine neuroendocrine and physiologic response following a psychosocial stressor in people with schizophrenia and healthy controls.
Description
We will administer the Trier Social Stress Test (TSST) and measure neuroendocrine values (plasma and salivary cortisol and adrenocorticotropic hormone (ACTH) and physiologic variables (heart rate, blood pressure) before during and after the TSST.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
To investigate neuroimmune and kynurenic acid modulation to a psychosocial stressor in people with schizophrenia and healthy controls
Description
We will measure peripheral cytokine response (IL-6, IL1-Beta, TNF alpha) and kynruenic acid, kynurenine and pathway metabolites before, during and after the TSST.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder (schizophrenia group) No DSM-IV Axis I or II disorder (healthy control group) Caucasian or Non-Caucasian Exclusion Criteria: History of Cushing's syndrome, adrenal deficiency, or any condition that may affect cortisol levels in the body. Use of steroids Pregnancy or lactation. Pregnancy will be determined by urine pregnancy test. Lactation will be determined through patient report. Untreated hypertension, cardiac arrthymias or medical condition that could not handle stress.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deanna L Kelly, PharmD, BCPP
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Psychiatric Research Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mprc.umaryland.edu
Description
Maryland Psychiatric Research Center

Learn more about this trial

Neuroendocrine and Immune Response to Stress in Schizophrenia

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