Neuroendocrine and Immune Response to Stress in Schizophrenia (TSST)

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Behavioral: Trier Social Stress Test

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • Maryland Psychiatric Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Trier Social Stress Test; 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.

Behavioral: Trier Social Stress Test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Deanna L Kelly, PharmD, BCPP, University of Maryland, College Park

Publications and helpful links

Helpful Links

• Maryland Psychiatric Research Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (Estimate): November 3, 2013

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: HP-00055151