Neuroendocrine and Immune Response to Stress in Schizophrenia

NCT01975584 | Completed

• 1 other identifier: HP-00055151
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 week

Study Arms (1)

Trier Social Stress Test

EXPERIMENTAL

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

Interventions

Trier Social Stress Test BEHAVIORAL

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.

Trier Social Stress Test

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

Related Links

• Maryland Psychiatric Research Center

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Deanna L Kelly, PharmD, BCPP

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm.D., BCPP

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 4, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

US (1)