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Clinical Trials/NCT01975584
NCT01975584
Completed
Not Applicable

Neuroendocrine and Immune Response to Stress in Schizophrenia

University of Maryland, Baltimore1 site in 1 country21 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of Maryland, Baltimore
Enrollment
21
Locations
1
Primary Endpoint
Aim 1) To examine neuroendocrine and physiologic response following a psychosocial stressor in people with schizophrenia and healthy controls.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
June 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deanna Kelly

Pharm.D., BCPP

University of Maryland, Baltimore

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.

Outcomes

Primary Outcomes

Aim 1) To examine neuroendocrine and physiologic response following a psychosocial stressor in people with schizophrenia and healthy controls.

Time Frame: 1 week

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 Outcomes

  • To investigate neuroimmune and kynurenic acid modulation to a psychosocial stressor in people with schizophrenia and healthy controls(1 week)

Study Sites (1)

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