Organic, Including Symptomatic, Mental DisordersCOMO-GMCNCT03847753
Exploring the Comorbidity Between Mental Disorders and General Medical Conditions
An observational study of Organic, Including Symptomatic, Mental Disorders and Substance Use, run by University of Aarhus.
Trial summary
Mental disorders have been shown to be associated with a number of general medical conditions (also referred to as somatic or physical conditions). The investigators aim to undertake a comprehensive study of comorbidity among those with treated mental disorders, by using high-quality Danish registers to provide age… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Organic, Including Symptomatic, Mental Disorders, Substance Use, Schizophrenia
- What is being tested?
- Organic Disorders, Substance Use Disorders and Schizophrenia Disorders
- How many people
- 5,940,299 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 31 Jan 2020
- How long will I take part?
- 17 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 1 year and older
- All sexes
- Child, Adult, Older adult
Study population: All individuals born in Denmark between 1900-2015 and who resided there between 2000-2016
Who may be able to join
- Born in Denmark between 1900-2015
- Resided in Denmark during the study period (2000-2016)
Who cannot join
- Excluded from analyses for each specific GMC, if considered a prevalent case of that GMC (i.e. ascertained to have a diagnosis for the GMC during the washout period of 1995-1999)
About this study
Official title: Exploring the Comorbidity Between Mental Disorders and General Medical Conditions Among a Danish National Population
Mental disorders have been shown to be associated with a number of general medical conditions (also referred to as somatic or physical conditions). The investigators aim to undertake a comprehensive study of comorbidity among those with treated mental disorders, by using high-quality Danish registers to provide age- and sex-specific pairwise estimates between the ten groups of mental disorders and nine groups of general medical conditions.
The investigators will examine the association between all 90 possible pairs of prior mental disorders and later GMC categories using the Danish national registers. Depending on whether individuals are diagnosed with a specific mental disorder, the investigators will estimate the risk of receiving a later diagnosis within a specific GMC category, between the start of follow-up (January 1, 2000) or at the earliest age at which a person might develop the mental disorder, whichever comes later. Follow-up will be terminated at onset of the GMC, death, emigration from Denmark, or December 31, 2016, whichever came first. Additionally for dyslipidemia, follow-up will be ended if a diagnosis of ischemic heart disease was received. A "wash-out" period will be employed in the five years before follow-up started (1995-1999), to identify and exclude prevalent cases from the analysis. Individuals with the GMC of interest before the observation period will be considered prevalent cases and excluded from the analyses (i.e. prevalent cases were "washed-out"). When estimating the risk of a specific GMC, the investigators will consider all individuals to be exposed or unexposed to the each mental disorder depending on whether a diagnosis is received before the end of follow-up. Persons will be considered unexposed to a mental disorder until the date of the first diagnosis, and exposed thereafter.
Read the detailed description
The investigators will analyse data from all individuals born in Denmark between 1900-2015 and who resided there between 2000-2016; giving a study size of over 5.5 million people. The National Patient Register, Cause of Death Register and National Prescription Registry of Denmark will all be used as sources of information about the mental disorders and general medical conditions (GMC) of interest. These are considered to be of high quality and validity.
The rate of diagnosis with a specific GMC group between those exposed and unexposed to each of ten mental disorders will be examined using hazard ratios (HRs) and 95% confidence intervals (CI), using Cox proportional hazards models with age as the underlying time scale. The following models will be run to provide all persons and sex-specific estimates, considering exposure to each mental disorder and whether the association differs depending on the time since onset of the mental disorder (lagged HRs):
Model A: adjusted for sex and birth date which, in combination with underlying age in the models, adjusts also for calendar time
Model B: additionally adjust for mental disorder comorbidity with onset before, but not after, the mental disorder of interest
Finally, cumulative incidence proportions of diagnosis with a GMC after being diagnosed with a mental disorder will be estimated. This will provide absolute risks of developing a GMC after a specific time, given a previous diagnosis of a mental disorder. To compare cumulative incidence proportions among people diagnosed with a mental disorder to those among people without a diagnosis, a matched reference group will be generated for each mental disorder. For every index person with the mental disorder, up to five age- and sex-matched individuals (who had not received a diagnosis of the relevant mental disorder by the age the index person was diagnosed) will be randomly selected. Cumulative incidence proportions will be generated for each reference group. All analyses will be performed on the secured platform of Statistics Denmark STATA/MP version 15.1 (Stata Corporation, College Station, Texas, USA).
An interactive webpage will be developed to visualize all results from this study. The Danish Data Protection Agency and the Danish Health Data Authority approved this study.
- Conditions
- Organic, Including Symptomatic, Mental Disorders, Substance Use, Schizophrenia, Mood [Affective] Disorders, Neurotic, Stress-related and Somatoform Disorders, Eating Disorder
- Being tested
- Organic Disorders, Substance Use Disorders, Schizophrenia Disorders, Mood disorders, Neurotic disorders
- Keywords
- Comorbidity
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Schizophrenia, Mood Disorders, Somatoform Disorders, Feeding and Eating Disorders, Behavior, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic DisordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Substance Use DisordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Schizophrenia DisordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Mood disordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Neurotic disordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Eating DisordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Personality DisordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Intellectual DisordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Developmental DisordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
Behavioral DisordersOther
Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
| Study group | Role | What they receive |
|---|---|---|
| Danish population | The cohort includes all those born in Denmark between 1900-2015, and who resided there in the period of 2000-2016.Whether they received a diagnosis of one of the following mental disorders will be ascertained: Organic Disorders, Substance Use Disorders, Schizophrenia Disorders, Mood Disorders, Eating Disorders, Neurotic Disorders, Personality Disorders, Intellectual Disorders, Developmental Disorders, Behavioral Disorders The risk of receiving a later diagnosis of one of the following types of general medical conditions will then be estimated: Circulatory, Endocrine, Pulmonary and Allergy, Gastrointestinal, Urogenital, Musculoskeletal, Hematological, Cancer, Neurological Receives: Other: Organic Disorders; Other: Substance Use Disorders; Other: Schizophrenia Disorders; Other: Mood disorders; Other: Neurotic disorders; Other: Eating Disorders; Other: Personality Disorders; Other: Intellectual Disorders; Other: Developmental Disorders; Other: Behavioral Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of circulatory system general medical conditions
These will be ascertained using the following criteria:
Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: hypertension, dyslipidemia, ischemic heart disease, atrial fibrillation, heart failure, peripheral arterial occlusive disease, stroke.
Records in the Danish National Prescription Register for at least one of the following types of medications: antihypertensives, lipid-lowering drugs, antianginal drugs (at least two prescriptions for a type of medication in one year).
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Risk of Endocrine System general medical conditions
These will be ascertained using the following criteria:
Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: diabetes mellitus, thyroid disorders, gout.
Records in the Danish National Prescription Register for at least one of the following types of medications: antidiabetic, thyroid therapy drugs (at least two prescriptions for a type of medication in one year).
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Risk of Pulmonary System general medical conditions
These will be ascertained using the following criteria:
Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: chronic pulmonary disease, allergy.
Records in the Danish National Prescription Register for at least one of the following types of medications: obstructive airway disease drugs, non-sedative antihistamines and/or nasal antiallergics (at least two prescriptions for a type of medication in one year).
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Risk of Gastrointestinal System general medical conditions
These will be ascertained using the following criteria:
Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: ulcer/chronic gastritis, chronic liver disease, inflammatory bowel disease, diverticular disease of intestine.
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Risk of Urogenital System general medical conditions
These will be ascertained using the following criteria:
Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: chronic kidney disease, prostate disorders.
Records in the Danish National Prescription Register for at least one of the following types of medications: prostate hyperplasia therapy drugs (at least two prescriptions for a type of medication in one year).
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Musculoskeletal System general medical conditions
These will be ascertained using the following criteria:
Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: connective tissue disorders, osteoporosis.
Records in the Danish National Prescription Register for at least one of the following types of medications: osteoporosis drugs (at least two prescriptions for a type of medication in one year) or repeated prescriptions for analgesics (at least four times in one year).
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Risk of Neurological System general medical conditions
These will be ascertained using the following criteria:
Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: vision problems, hearing problems, migraine, epilepsy*, Parkinson's Disease, multiple sclerosis, neuropathies.
Records in the Danish National Prescription Register for at least one of the following types of medications: specific anti-migraine drugs, antiepileptic drugs* (at least two prescriptions for a type of medication in one year)
*Both a diagnosis of epilepsy AND two prescriptions of an antiepileptic drug in one year are required.
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Risk of Hematological System general medical conditions
These will be ascertained using the following criteria:
Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: HIV/AIDS, anemias.
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Risk of Cancers
These will be ascertained using the following criteria:
Cancer diagnosis in the Danish National Patient Register or death in the Cause of Death register.
Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Measured: Diagnosed during the study period (2000-2016), after at least 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jan 2000
- Primary completion31 Dec 2016
- Study completion31 Jan 2020
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 Organic, Including Symptomatic, Mental DisordersStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,940,299 participants (actual)
- Target duration
- 17 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John J McGrath, MD, PhD, Principal investigator, National Centre for Register-Based Research, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847753
- Sponsor's protocol ID
- COMO-GMC
- Acronym
- COMO-GMC
- Status last verified
- Apr 2020
- First submitted
- 7 Feb 2019
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Momen NC, Plana-Ripoll O, Agerbo E, Benros ME, Borglum AD, Christensen MK, Dalsgaard S, Degenhardt L, de Jonge P, Debost JPG, Fenger-Gron M, Gunn JM, Iburg KM, Kessing LV, Kessler RC, Laursen TM, Lim CCW, Mors O, Mortensen PB, Musliner KL, Nordentoft M, Pedersen CB, Petersen LV, Ribe AR, Roest AM, Saha S, Schork AJ, Scott KM, Sievert C, Sorensen HJ, Stedman TJ, Vestergaard M, Vilhjalmsson B, Werge T, Weye N, Whiteford HA, Prior A, McGrath JJ. Association between Mental Disorders and Subsequent Medical Conditions. N Engl J Med. 2020 Apr 30;382(18):1721-1731. doi: 10.1056/NEJMoa1915784.
PubMed 32348643
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Comorbidity Between Mental Disorders and General Medical Conditions Among a Danish National Population
- ClinicalTrials.gov ID
- NCT03847753
- Acronym / sponsor ID
- COMO-GMC / COMO-GMC
- Conditions
- Organic, Including Symptomatic, Mental Disorders, Substance Use, Schizophrenia, Mood [Affective] Disorders, Neurotic, Stress-related and Somatoform Disorders, Eating Disorder
- Keywords
- Comorbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,940,299 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 20 Feb 2019 (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.
Mental disorders have been shown to be associated with a number of general medical conditions (also referred to as somatic or physical conditions). The investigators aim to undertake a comprehensive study of comorbidity among those with treated mental disorders, by using high-quality Danish registers to provide age- and sex-specific pairwise estimates between the ten groups of mental disorders and nine groups of general medical conditions.
The investigators will examine the association between all 90 possible pairs of prior mental disorders and later GMC categories using the Danish national registers. Depending on whether individuals are diagnosed with a specific mental disorder, the investigators will estimate the risk of receiving a later diagnosis within a specific GMC category, between the start of follow-up (January 1, 2000) or at the earliest age at which a person might develop the mental disorder, whichever comes later. Follow-up will be terminated at onset of the GMC, death, emigration from Denmark, or December 31, 2016, whichever came first. Additionally for dyslipidemia, follow-up will be ended if a diagnosis of ischemic heart disease was received. A "wash-out" period will be employed in the five years before follow-up started (1995-1999), to identify and exclude prevalent cases from the analysis. Individuals with the GMC of interest before the observation period will be considered prevalent cases and excluded from the analyses (i.e. prevalent cases were "washed-out"). When estimating the risk of a specific GMC, the investigators will consider all individuals to be exposed or unexposed to the each mental disorder depending on whether a diagnosis is received before the end of follow-up. Persons will be considered unexposed to a mental disorder until the date of the first diagnosis, and exposed thereafter.
Detailed description
The investigators will analyse data from all individuals born in Denmark between 1900-2015 and who resided there between 2000-2016; giving a study size of over 5.5 million people. The National Patient Register, Cause of Death Register and National Prescription Registry of Denmark will all be used as sources of information about the mental disorders and general medical conditions (GMC) of interest. These are considered to be of high quality and validity.
The rate of diagnosis with a specific GMC group between those exposed and unexposed to each of ten mental disorders will be examined using hazard ratios (HRs) and 95% confidence intervals (CI), using Cox proportional hazards models with age as the underlying time scale. The following models will be run to provide all persons and sex-specific estimates, considering exposure to each mental disorder and whether the association differs depending on the time since onset of the mental disorder (lagged HRs):
Model A: adjusted for sex and birth date which, in combination with underlying age in the models, adjusts also for calendar time
Model B: additionally adjust for mental disorder comorbidity with onset before, but not after, the mental disorder of interest
Finally, cumulative incidence proportions of diagnosis with a GMC after being diagnosed with a mental disorder will be estimated. This will provide absolute risks of developing a GMC after a specific time, given a previous diagnosis of a mental disorder. To compare cumulative incidence proportions among people diagnosed with a mental disorder to those among people without a diagnosis, a matched reference group will be generated for each mental disorder. For every index person with the mental disorder, up to five age- and sex-matched individuals (who had not received a diagnosis of the relevant mental disorder by the age the index person was diagnosed) will be randomly selected. Cumulative incidence proportions will be generated for each reference group. All analyses will be performed on the secured platform of Statistics Denmark STATA/MP version 15.1 (Stata Corporation, College Station, Texas, USA).
An interactive webpage will be developed to visualize all results from this study. The Danish Data Protection Agency and the Danish Health Data Authority approved this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 17 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Danish population | – | Other: Organic Disorders, Other: Substance Use Disorders, Other: Schizophrenia Disorders, Other: Mood disorders, Other: Neurotic disorders, Other: Eating Disorders, Other: Personality Disorders, Other: Intellectual Disorders, Other: Developmental Disorders, Other: Behavioral DisordersThe cohort includes all those born in Denmark between 1900-2015, and who resided there in the period of 2000-2016.Whether they received a diagnosis of one of the following mental disorders will be ascertained: Organic Disorders, Substance Use Disorders, Schizophrenia Disorders, Mood Disorders, Eating Disorders, Neurotic Disorders, Personality Disorders, Intellectual Disorders, Developmental Disorders, Behavioral Disorders The risk of receiving a later diagnosis of one of the following types of general medical conditions will then be estimated: Circulatory, Endocrine, Pulmonary and Allergy, Gastrointestinal, Urogenital, Musculoskeletal, Hematological, Cancer, Neurological |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals born in Denmark between 1900-2015 and who resided there between 2000-2016
Key inclusion criteria (2 listed)
- Born in Denmark between 1900-2015
- Resided in Denmark during the study period (2000-2016)
Key exclusion criteria (1 listed)
- Excluded from analyses for each specific GMC, if considered a prevalent case of that GMC (i.e. ascertained to have a diagnosis for the GMC during the washout period of 1995-1999)
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 |
|---|---|---|
| Organic DisordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Substance Use DisordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Schizophrenia DisordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Mood disordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Neurotic disordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Eating DisordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Personality DisordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Intellectual DisordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Developmental DisordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
| Behavioral DisordersIndividuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register. | Other | Danish population |
Primary outcome
Risk of circulatory system general medical conditions
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: hypertension, dyslipidemia, ischemic heart disease, atrial fibrillation, heart failure, peripheral arterial occlusive disease, stroke. Records in the Danish National Prescription Register for at least one of the following types of medications: antihypertensives, lipid-lowering drugs, antianginal drugs (at least two prescriptions for a type of medication in one year). Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Risk of Endocrine System general medical conditions
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: diabetes mellitus, thyroid disorders, gout. Records in the Danish National Prescription Register for at least one of the following types of medications: antidiabetic, thyroid therapy drugs (at least two prescriptions for a type of medication in one year). Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Risk of Pulmonary System general medical conditions
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: chronic pulmonary disease, allergy. Records in the Danish National Prescription Register for at least one of the following types of medications: obstructive airway disease drugs, non-sedative antihistamines and/or nasal antiallergics (at least two prescriptions for a type of medication in one year). Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Risk of Gastrointestinal System general medical conditions
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: ulcer/chronic gastritis, chronic liver disease, inflammatory bowel disease, diverticular disease of intestine. Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Risk of Urogenital System general medical conditions
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: chronic kidney disease, prostate disorders. Records in the Danish National Prescription Register for at least one of the following types of medications: prostate hyperplasia therapy drugs (at least two prescriptions for a type of medication in one year). Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Musculoskeletal System general medical conditions
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: connective tissue disorders, osteoporosis. Records in the Danish National Prescription Register for at least one of the following types of medications: osteoporosis drugs (at least two prescriptions for a type of medication in one year) or repeated prescriptions for analgesics (at least four times in one year). Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Risk of Neurological System general medical conditions
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: vision problems, hearing problems, migraine, epilepsy*, Parkinson's Disease, multiple sclerosis, neuropathies. Records in the Danish National Prescription Register for at least one of the following types of medications: specific anti-migraine drugs, antiepileptic drugs* (at least two prescriptions for a type of medication in one year) *Both a diagnosis of epilepsy AND two prescriptions of an antiepileptic drug in one year are required. Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Risk of Hematological System general medical conditions
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Diagnosis in the Danish National Patient Register or death in the Cause of Death register, for at least one of the following diseases: HIV/AIDS, anemias. Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
Risk of Cancers
Time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age
These will be ascertained using the following criteria: Cancer diagnosis in the Danish National Patient Register or death in the Cause of Death register. Hazard ratios (HRs), with 95% confidence intervals, will be obtained to compare risk of diagnosis with a general medical condition in those with previous mental disorders, compared to those without. All persons, sex-specific and lagged (accounting for time since mental disorder diagnosis) HRs will be obtained. Additionally absolute risks will be calculated.
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 22 May 2020.
- Derived from this study: PubMed 32348643Momen NC, Plana-Ripoll O, Agerbo E, Benros ME, Borglum AD, Christensen MK, Dalsgaard S, Degenhardt L, de Jonge P, Debost JPG, Fenger-Gron M, Gunn JM, Iburg KM, Kessing LV, Kessler RC, Laursen TM, Lim CCW, Mors O, Mortensen PB, Musliner KL, Nordentoft M, Pedersen CB, Petersen LV, Ribe AR, Roest AM, Saha S, Schork AJ, Scott KM, Sievert C, Sorensen HJ, Stedman TJ, Vestergaard M, Vilhjalmsson B, Werge T, Weye N, Whiteford HA, Prior A, McGrath JJ. Association between Mental Disorders and Subsequent Medical Conditions. N Engl J Med. 2020 Apr 30;382(18):1721-1731. doi: 10.1056/NEJMoa1915784.
- Individual participant dataSharing planned: No
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.
John J McGrath, MD, PhD principal investigator
National Centre for Register-Based Research, Aarhus University
Questions about this trial
What is this clinical trial studying?
An observational study of Organic, Including Symptomatic, Mental Disorders and Substance Use, run by University of Aarhus.
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 2 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Risk of circulatory system general medical conditions (time frame: Diagnosed during the study period (2000-2016), after at least 1 year of age). The study lists 9 primary outcomes in all. 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 NCT03847753, 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 22 May 2020.