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Exploring the Comorbidity Between Mental Disorders and General Medical Conditions (COMO-GMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03847753
Recruitment Status : Active, not recruiting
First Posted : February 20, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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- 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.


Condition or disease Intervention/treatment
Organic, Including Symptomatic, Mental Disorders Substance Use Schizophrenia Mood [Affective] Disorders Neurotic, Stress-related and Somatoform Disorders Eating Disorder Disorders of Adult Personality and Behavior Mental Retardation Disorder of Psychological Development Behavioural Disorder Hypertension Dyslipidemias Ischemic Heart Disease Atrial Fibrillation Heart Failure Peripheral Occlusive Disease Stroke Diabetes Mellitus Thyroid Disorder Gout Chronic Pulmonary Disease Allergy Chronic Gastritis Chronic Liver Disease Inflammatory Bowel Diseases Diverticular Disease of Large Intestine Chronic Kidney Diseases Prostate Disorders Connective Tissue Disorder Osteoporosis Pain HIV/AIDS Anemia Cancer Vision Disorders Hearing Disorders Migraine Epilepsy Parkinson Disease Multiple Sclerosis Neuropathy 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

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 5940299 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 17 Years
Official Title: Exploring the Comorbidity Between Mental Disorders and General Medical Conditions Among a Danish National Population
Actual Study Start Date : January 1, 2000
Actual Primary Completion Date : December 31, 2016
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other: Organic Disorders
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.

Other: Substance Use Disorders
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.

Other: Schizophrenia Disorders
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.

Other: Mood disorders
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.

Other: Neurotic disorders
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.

Other: Eating Disorders
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.

Other: Personality Disorders
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.

Other: Intellectual Disorders
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.

Other: Developmental Disorders
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.

Other: Behavioral Disorders
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.




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.


  8. 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.


  9. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All individuals born in Denmark between 1900-2015 and who resided there between 2000-2016
Criteria

Inclusion Criteria:

  • Born in Denmark between 1900-2015
  • Resided in Denmark during the study period (2000-2016)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847753


Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: John J McGrath, MD, PhD National Centre for Register-Based Research, Aarhus University

Additional Information:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03847753    
Other Study ID Numbers: COMO-GMC
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Comorbidity
Additional relevant MeSH terms:
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Diverticular Diseases
Diverticulum
Osteoporosis
Liver Diseases
Inflammatory Bowel Diseases
Gastritis
Hearing Disorders
Parkinson Disease
Multiple Sclerosis
Intellectual Disability
Vision Disorders
Kidney Diseases
Renal Insufficiency, Chronic
Atrial Fibrillation
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Connective Tissue Diseases
Dyslipidemias
Disease
Feeding and Eating Disorders
Mental Disorders
Psychotic Disorders
Somatoform Disorders
Mood Disorders
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Parkinsonian Disorders