Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03334045 |
| Other study ID # |
OP_483 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2018 |
| Est. completion date |
March 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Odense University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 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.
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.
