SchizophreniaTSSTNCT01975584
Neuroendocrine and Immune Response to Stress in Schizophrenia
A study testing Trier Social Stress Test in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Trier Social Stress Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Trier Social Stress Test
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TestBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Trier Social Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deanna Kelly, University of Maryland, Baltimore
- Investigators
- Deanna L Kelly, PharmD, BCPP, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975584
- Sponsor's protocol ID
- HP-00055151
- Acronym
- TSST
- Status last verified
- Sep 2019
- First submitted
- 18 Oct 2013
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine and Immune Response to Stress in Schizophrenia
- ClinicalTrials.gov ID
- NCT01975584
- Acronym / sponsor ID
- TSST / HP-00055151
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trier Social Stress Test | Experimental | Behavioral: Trier Social Stress TestParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trier Social Stress TestParticipants 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. | Behavioural | Trier Social Stress Test |
Primary outcome
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.
1 secondary outcome
To investigate neuroimmune and kynurenic acid modulation to a psychosocial stressor in people with schizophrenia and healthy controls
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Maryland Psychiatric Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna L Kelly, PharmD, BCPP principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier Social Stress Test in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1) To examine neuroendocrine and physiologic response following a psychosocial stressor in people with schizophrenia and healthy controls. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.