NCT03847753

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,940,299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

May 22, 2020

Status Verified

April 1, 2020

Enrollment Period

17 years

First QC Date

February 7, 2019

Last Update Submit

May 22, 2020

Conditions

Keywords

Comorbidity

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Diagnosed during the study period (2000-2016), after at least 1 year of age

Study Arms (1)

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 DisordersOther: Substance Use DisordersOther: Schizophrenia DisordersOther: Mood disordersOther: Neurotic disordersOther: Eating DisordersOther: Personality DisordersOther: Intellectual DisordersOther: Developmental DisordersOther: Behavioral Disorders

Interventions

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.

Danish population

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.

Danish population

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.

Danish population

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.

Danish population

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.

Danish population

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.

Danish population

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.

Danish population

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.

Danish population

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.

Danish population

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.

Danish population

Eligibility Criteria

Age1 Year+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individuals born in Denmark between 1900-2015 and who resided there between 2000-2016

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mental DisordersSubstance-Related DisordersSchizophreniaMood DisordersSomatoform DisordersFeeding and Eating DisordersBehaviorIntellectual DisabilityHypertensionDyslipidemiasMyocardial IschemiaAtrial FibrillationHeart FailureStrokeDiabetes MellitusThyroid DiseasesGoutHypersensitivityInflammatory Bowel DiseasesRenal Insufficiency, ChronicProstatic DiseasesConnective Tissue DiseasesOsteoporosisPainAcquired Immunodeficiency SyndromeAnemiaNeoplasmsVision DisordersHearing DisordersMigraine DisordersEpilepsyParkinson DiseaseMultiple Sclerosis

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersSchizophrenia Spectrum and Other Psychotic DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesNeurodevelopmental DisordersVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesArrhythmias, CardiacPathologic ProcessesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesGlucose Metabolism DisordersEndocrine System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmune System DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesGenital Diseases, MaleGenital DiseasesSkin and Connective Tissue DiseasesBone Diseases, MetabolicBone DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesImmunologic Deficiency SyndromesHematologic DiseasesHemic and Lymphatic DiseasesSensation DisordersEye DiseasesEar DiseasesOtorhinolaryngologic DiseasesHeadache Disorders, PrimaryHeadache DisordersParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune Diseases

Study Officials

  • John J McGrath, MD, PhD

    National Centre for Register-Based Research, Aarhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
17 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 20, 2019

Study Start

January 1, 2000

Primary Completion

December 31, 2016

Study Completion

January 31, 2020

Last Updated

May 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share