Neurobiological Effects of Work-related Adjustment Disorder

NCT03334045 | Unknown DMC

• 1 other identifier: OP_483
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adjustment Disorder With Work Inhibition

Keywords

Neurobiology; Occupational Stress; Dopamine

Outcome Measures

Primary Outcomes (1)

• Glucose metabolism

  PET/MR scan

  3 year

Secondary Outcomes (1)

• Dopamine binding potential

  3-4 years

Study Arms (2)

Stress patients

Patients diagnosed with work-related Adjustment disorder

Radiation: PET/MR scans

Controls

Healthy controls

Radiation: PET/MR scans

Interventions

PET/MR scans RADIATION

Observations of glucose metabolism and dopamine binding potential

Controls; Stress patients

Eligibility Criteria

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

Study Population

The patients are recruited among women aged 18-64 years.

You may qualify if:

• Population and controls:
• Informed consent before study-related activity
• Aged 18 - 64
• Labour market suitability
• Study population:
• Patients: F43.2

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30382017 DERIVED

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Saga Steinmann Madsen, Engineering

  OUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Engineer

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: November 7, 2017
• Study Start: May 1, 2018
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)