Clinical trial NCT01975584: Neuroendocrine and Immune Response to Stress in Schizophrenia
Official title: Neuroendocrine and Immune Response to Stress in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Aim 1) To examine neuroendocrine and physiologic response following a psychosocial stressor in people with schizophrenia and healthy controls.
timeFrame: 1 week
Secondary outcomes:
measure: To investigate neuroimmune and kynurenic acid modulation to a psychosocial stressor in people with schizophrenia and healthy controls
timeFrame: 1 week
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Deanna L Kelly, PharmD, BCPP
role: PRINCIPAL_INVESTIGATOR
References: