Adjustment Disorder With Work InhibitionNeuroWADNCT03334045
Neurobiological Effects of Work-related Adjustment Disorder
An observational study of Adjustment Disorder With Work Inhibition, run by Odense University Hospital at 1 site in Denmark.
Trial summary
INTRODUCTION: Stress is one of the greatest burdens of our society and often imply impairments in cognitive and emotional functions. The investigators hypothesize that changes in the brain's dopamine(DA)-based mesocorticolimbic projections in patients with work-related stress (adjustment disorder) will manifest in… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Adjustment Disorder With Work Inhibition
- What is being tested?
- PET/MR scans
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to Mar 2023
- How long will I take part?
- 2 Years
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The patients are recruited among women aged 18-64 years.
Who may be able to join
- Population and controls:
- Informed consent before study-related activity
- Aged 18 - 64
- Labour market suitability
- Study population:
- Patients: F43.2
- Controls: Healthy individuals that meet the following inclusion and
Who cannot join
- Population, patients and controls:
- Comorbid diagnoses as for instance: cancer, cardiovascular disease, diabetes.
- Regular medication known to affect the central nervous system.
- Prior exposure to violence and other serious harassment in the workplace
- Psychosocial challenge in private life according to the screening criteria in the protocol.
- Other serious illness
Show all 12Show fewer
- Metal in body
- Claustrophobia
- Pregnancy
- Confounding drug consumption
- Dependence e.g. alcohol, narcotics or other
- Persons within a period of 1 year have participated in scientific studies that use isotopes, or who have had greater diagnostic tests that utilize ionizing radiation.
Trial locations and contacts
1 site in 1 country.
About this study
INTRODUCTION: Stress is one of the greatest burdens of our society and often imply impairments in cognitive and emotional functions. The investigators hypothesize that changes in the brain's dopamine(DA)-based mesocorticolimbic projections in patients with work-related stress (adjustment disorder) will manifest in altered glucose metabolism in relation to neural activity and altered DA radiotracer binding potential at neurotransmitter and receptor level.
MATERIAL AND METHODS: Subjects and healthy controls undergo neuropsychiatric tests and PET/MR imaging with three tracers: [18F]FDG to measure glucose metabolism as a marker of neural activity, [11C]raclopride to investigate the DA binding potential in the striatum, and [11C]FLB 457 to study possible impaired mesocortical dopaminergic transmission. To demonstrate difference in glucose metabolism ≥2x41 patients/controls are needed.
Read more
OUTCOME: The investigators expect to find that symptoms of cognitive and motivational/reward deficits could be attributable to changes in frontal lobe and striatal glucose metabolism in >50% of patients and that changes in striatal D2 receptors and impaired mesocortical dopaminergic transmission in the prefrontal cortex are contributing factors.
CONCLUSION: This project aims to generate entirely new and objective evidence of stress-induced cerebral illness and provide a basis for in depth research and more rational management of this strenuous disorder.
Read the detailed description
Recruitment procedure: The department of Occupational and Environmental Medicine (DOE) at OUH have developed a screening procedure to recruit patients diagnosed according to the ICD10 F43.2x, and exposed to predominant psychosocial work stressors. The patients are recruited among women and men aged 18-64. At the DOE subjects undergo a clinical diagnostic interview based on the ICD 10 criteria including screening for stressors in the psychosocial work environment and their relationship to disease development, private life strains, personal back-ground, mental vulnerability, and competing somatic disease, as well as tests for depression and anxiety symptoms, respectively the Beck Anxiety Inventory (BAI) and Major Depression Inventory (MDI). The psychosocial work environ-ment stressors being screened for are: quantitative demands, emotional demands, role conflict, role ambiguity, sup-port and encouragement, organizational justice, adequate education and training (skill level). The experience of stressors is assessed in relation to the most dominant stress models, "demand-control-support" (Karasek), "effort and reward imbalance at work" (Siegrist), "Stress as Offense two self" (Semmer), and classical stress theory focusing on appraisal / coping (Lazarus or Ursin).
The procedure is onward going to be performed automatically in an online environment. Due to the nature of neurobiology the scans must be conducted within a fairly short time period after the initial diagnosis. Hence a declaration of consent will be presented and signed at the day of the first scan, also ensuring that all additional questions can be answered by the main investigator. The scans will be conducted within a fortnight after the fists contact. In connection with the scans, the main investigator will conduct an SCAN-PSE interview for the assessment of mental symptoms to determine if the participant's condition has changed since they decided to participate in the trial. Healthy controls are recruited and matched with regard to gender, age, educational and occupational background. Further, controls are screened for confounding factors in a similar manner as the patient group.
- Conditions
- Adjustment Disorder With Work Inhibition
- Being tested
- PET/MR scans
- Keywords
- Neurobiology, Occupational Stress, Dopamine
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR scansRadiation
Observations of glucose metabolism and dopamine binding potential
| Study group | Role | What they receive |
|---|---|---|
| Stress patients | Patients diagnosed with work-related Adjustment disorder Receives: Radiation: PET/MR scans | |
| Controls | Healthy controls Receives: Radiation: PET/MR scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolism
PET/MR scan
Measured: 3 year
Secondary outcomes (1)
Dopamine binding potential
PET/MR scan
Measured: 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 May 2018
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjustment Disorder With Work InhibitionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 82 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saga Steinmann Madsen, Odense University Hospital
- Investigators
- Saga Steinmann Madsen, Engineering, Principal investigator, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334045
- Sponsor's protocol ID
- OP_483
- Acronym
- NeuroWAD
- Status last verified
- Sep 2022
- First submitted
- 13 Oct 2017
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madsen SS, Gjedde A, Brandt L, Pihl-Thingvad J, Videbech P, Gerke O, Hojlund-Carlsen PF. Neurobiological effects of work-related stress: protocol for a case-control neuroimaging study. Dan Med J. 2018 Nov;65(11):A5513.
PubMed 30382017
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Effects of Work-related Adjustment Disorder
- ClinicalTrials.gov ID
- NCT03334045
- Acronym / sponsor ID
- NeuroWAD / OP_483
- Conditions
- Adjustment Disorder With Work Inhibition
- Keywords
- Neurobiology, Occupational Stress, Dopamine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 May 2018 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 7 Nov 2017 (actual)
- 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.
INTRODUCTION: Stress is one of the greatest burdens of our society and often imply impairments in cognitive and emotional functions. The investigators hypothesize that changes in the brain's dopamine(DA)-based mesocorticolimbic projections in patients with work-related stress (adjustment disorder) will manifest in altered glucose metabolism in relation to neural activity and altered DA radiotracer binding potential at neurotransmitter and receptor level.
MATERIAL AND METHODS: Subjects and healthy controls undergo neuropsychiatric tests and PET/MR imaging with three tracers: [18F]FDG to measure glucose metabolism as a marker of neural activity, [11C]raclopride to investigate the DA binding potential in the striatum, and [11C]FLB 457 to study possible impaired mesocortical dopaminergic transmission. To demonstrate difference in glucose metabolism ≥2x41 patients/controls are needed.
OUTCOME: The investigators expect to find that symptoms of cognitive and motivational/reward deficits could be attributable to changes in frontal lobe and striatal glucose metabolism in >50% of patients and that changes in striatal D2 receptors and impaired mesocortical dopaminergic transmission in the prefrontal cortex are contributing factors.
CONCLUSION: This project aims to generate entirely new and objective evidence of stress-induced cerebral illness and provide a basis for in depth research and more rational management of this strenuous disorder.
Detailed description
Recruitment procedure: The department of Occupational and Environmental Medicine (DOE) at OUH have developed a screening procedure to recruit patients diagnosed according to the ICD10 F43.2x, and exposed to predominant psychosocial work stressors. The patients are recruited among women and men aged 18-64. At the DOE subjects undergo a clinical diagnostic interview based on the ICD 10 criteria including screening for stressors in the psychosocial work environment and their relationship to disease development, private life strains, personal back-ground, mental vulnerability, and competing somatic disease, as well as tests for depression and anxiety symptoms, respectively the Beck Anxiety Inventory (BAI) and Major Depression Inventory (MDI). The psychosocial work environ-ment stressors being screened for are: quantitative demands, emotional demands, role conflict, role ambiguity, sup-port and encouragement, organizational justice, adequate education and training (skill level). The experience of stressors is assessed in relation to the most dominant stress models, "demand-control-support" (Karasek), "effort and reward imbalance at work" (Siegrist), "Stress as Offense two self" (Semmer), and classical stress theory focusing on appraisal / coping (Lazarus or Ursin).
The procedure is onward going to be performed automatically in an online environment. Due to the nature of neurobiology the scans must be conducted within a fairly short time period after the initial diagnosis. Hence a declaration of consent will be presented and signed at the day of the first scan, also ensuring that all additional questions can be answered by the main investigator. The scans will be conducted within a fortnight after the fists contact. In connection with the scans, the main investigator will conduct an SCAN-PSE interview for the assessment of mental symptoms to determine if the participant's condition has changed since they decided to participate in the trial. Healthy controls are recruited and matched with regard to gender, age, educational and occupational background. Further, controls are screened for confounding factors in a similar manner as the patient group.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress patients | – | Radiation: PET/MR scansPatients diagnosed with work-related Adjustment disorder |
| Controls | – | Radiation: PET/MR scansHealthy controls |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The patients are recruited among women aged 18-64 years.
Key inclusion criteria (7 listed)
- Informed consent before study-related activity
- Aged 18 - 64
- Labour market suitability
- Patients: F43.2
- Controls: Healthy individuals that meet the following inclusion and
Key exclusion criteria (12 listed)
- Comorbid diagnoses as for instance: cancer, cardiovascular disease, diabetes.
- Regular medication known to affect the central nervous system.
- Prior exposure to violence and other serious harassment in the workplace
- Psychosocial challenge in private life according to the screening criteria in the protocol.
- Other serious illness
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 |
|---|---|---|
| PET/MR scansObservations of glucose metabolism and dopamine binding potential | Radiation | Controls, Stress patients |
Primary outcome
Glucose metabolism
Time frame: 3 year
PET/MR scan
1 secondary outcome
Dopamine binding potential
Time frame: 3-4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 30382017Madsen SS, Gjedde A, Brandt L, Pihl-Thingvad J, Videbech P, Gerke O, Hojlund-Carlsen PF. Neurobiological effects of work-related stress: protocol for a case-control neuroimaging study. Dan Med J. 2018 Nov;65(11):A5513.
- 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.
Saga Steinmann Madsen, Engineering principal investigator
OUH
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 Adjustment Disorder With Work Inhibition, run by Odense University Hospital at 1 site in Denmark.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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 Denmark. 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?
Results are not available in the source record.
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?
Glucose metabolism (time frame: 3 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 NCT03334045, which also lists 1 linked publication.
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 23 Sep 2022.