Stress Disorders, TraumaticNCT00184418
The Immune System and Psychiatric Disorders
An observational study of Stress Disorders, Traumatic and Depressive Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The study is based on a hypothesis that there is interaction between the activity in the immune system and in the mind. To study this, the investigators register different measures for activity in the immune system on patients unselectedly admitted to an acute psychiatric ward. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress Disorders, Traumatic, Depressive Disorder, Bipolar Disorder
- How many people
- 1,400 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Jan 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults aged 18 years and above. Amitted to psychiatric acute ward of St Olavs Hospital, Trondheim, Norway.
Who may be able to join
- Admission to the adult acute psychiatric ward of a certain geographical area during the study period
Who cannot join
- Patients that do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Norway1 site
St Olavs Hospital, Department of Psychiatry, Østmarka Hospital
Trondheim, Middle Norway, N-7040
About this study
The study is based on a hypothesis that there is interaction between the activity in the immune system and in the mind. To study this, the investigators register different measures for activity in the immune system on patients unselectedly admitted to an acute psychiatric ward. The psychiatric statuses and diagnoses of these patients are carefully defined as well.
Read the detailed description
Our hypotheses are first that activity in the immune system influences the psychiatric status in general, second that changes in activity in psychiatric status affect activity in the immune system and third that there are connections between certain psychiatric conditions/disorders and certain features of the immune system.
All patients admitted to a psychiatric acute ward covering an area with a population of 130.000 and with around 1000 admittances to an acute psychiatric ward a year (some readmittances) are asked to participate in the study. Patients fill in a question form regarding psychiatric as well as somatic health with emphasis on diseases involving immune activity. When possible also slight information on the family is registered. Both at the time of admittance and after recovery clinical laboratory tests on somatic status are registered. In addition the level of different cytokines is measured. The psychiatric state and precise diagnoses are registered during the stay. The data will be analysed to uncover connections between psychiatric stress in general as well as specific psychiatric diagnoses and activity in the immune system.
- Conditions
- Stress Disorders, Traumatic, Depressive Disorder, Bipolar Disorder, Personality Disorders, Schizophrenia, Psychotic Disorders
- Keywords
- Immunity, Immune System, Cytokines, Psychophysiology, Psychoneuroimmunology
- Medical subject headings
- Stress Disorders, Traumatic, Depressive Disorder, Bipolar Disorder, Personality Disorders, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients admitted to a psychiatric acute ward | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokines
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, TraumaticStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Solveig K Reitan, MD, PhD, Study chair, St Olavs Hospital/NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184418
- Sponsor's protocol ID
- 94463
- Status last verified
- Mar 2017
- First submitted
- 15 Sep 2005
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saether SG, Schou M, Stoecker W, Teegen B, Borowski K, Vaaler A, Kondziella D, Reitan SK. Onconeural Antibodies in Acute Psychiatric Inpatient Care. J Neuropsychiatry Clin Neurosci. 2017 Winter;29(1):74-76. doi: 10.1176/appi.neuropsych.16050110. Epub 2016 Aug 31.
PubMed 27578448Schou M, Saether SG, Borowski K, Teegen B, Kondziella D, Stoecker W, Vaaler A, Reitan SK. Prevalence of serum anti-neuronal autoantibodies in patients admitted to acute psychiatric care. Psychol Med. 2016 Dec;46(16):3303-3313. doi: 10.1017/S0033291716002038. Epub 2016 Sep 9.
PubMed 27609625Sakai Y, Iversen V, Reitan SK. FT4 and TSH, relation to diagnoses in an unselected psychiatric acute-ward population, and change during acute psychiatric admission. BMC Psychiatry. 2018 Jul 28;18(1):244. doi: 10.1186/s12888-018-1819-3.
PubMed 30055589
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune System and Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT00184418
- Acronym / sponsor ID
- 94463
- Conditions
- Stress Disorders, Traumatic, Depressive Disorder, Bipolar Disorder, Personality Disorders, Schizophrenia, Psychotic Disorders
- Keywords
- Immunity, Immune System, Cytokines, Psychophysiology, Psychoneuroimmunology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Jan 2005 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Sep 2005 (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.
The study is based on a hypothesis that there is interaction between the activity in the immune system and in the mind. To study this, the investigators register different measures for activity in the immune system on patients unselectedly admitted to an acute psychiatric ward. The psychiatric statuses and diagnoses of these patients are carefully defined as well.
Detailed description
Our hypotheses are first that activity in the immune system influences the psychiatric status in general, second that changes in activity in psychiatric status affect activity in the immune system and third that there are connections between certain psychiatric conditions/disorders and certain features of the immune system.
All patients admitted to a psychiatric acute ward covering an area with a population of 130.000 and with around 1000 admittances to an acute psychiatric ward a year (some readmittances) are asked to participate in the study. Patients fill in a question form regarding psychiatric as well as somatic health with emphasis on diseases involving immune activity. When possible also slight information on the family is registered. Both at the time of admittance and after recovery clinical laboratory tests on somatic status are registered. In addition the level of different cytokines is measured. The psychiatric state and precise diagnoses are registered during the stay. The data will be analysed to uncover connections between psychiatric stress in general as well as specific psychiatric diagnoses and activity in the immune system.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients admitted to a psychiatric acute ward | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults aged 18 years and above. Amitted to psychiatric acute ward of St Olavs Hospital, Trondheim, Norway.
Key inclusion criteria (1 listed)
- Admission to the adult acute psychiatric ward of a certain geographical area during the study period
Key exclusion criteria (1 listed)
- Patients that do not agree to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cytokines
Time frame: 1 year
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 13 Mar 2017.
- Results publication: PubMed 27578448Saether SG, Schou M, Stoecker W, Teegen B, Borowski K, Vaaler A, Kondziella D, Reitan SK. Onconeural Antibodies in Acute Psychiatric Inpatient Care. J Neuropsychiatry Clin Neurosci. 2017 Winter;29(1):74-76. doi: 10.1176/appi.neuropsych.16050110. Epub 2016 Aug 31.
- Results publication: PubMed 27609625Schou M, Saether SG, Borowski K, Teegen B, Kondziella D, Stoecker W, Vaaler A, Reitan SK. Prevalence of serum anti-neuronal autoantibodies in patients admitted to acute psychiatric care. Psychol Med. 2016 Dec;46(16):3303-3313. doi: 10.1017/S0033291716002038. Epub 2016 Sep 9.
- Derived from this study: PubMed 30055589Sakai Y, Iversen V, Reitan SK. FT4 and TSH, relation to diagnoses in an unselected psychiatric acute-ward population, and change during acute psychiatric admission. BMC Psychiatry. 2018 Jul 28;18(1):244. doi: 10.1186/s12888-018-1819-3.
- Individual participant dataSharing planned: No
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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.
Solveig K Reitan, MD, PhD study chair
St Olavs Hospital/NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Traumatic and Depressive Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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 13 Mar 2017. 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 Norway. 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?
cytokines (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184418, which also lists 3 linked publications.
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 13 Mar 2017.