Exploring the Comorbidity Between Mental Disorders and General Medical Conditions

NCT ID: NCT03847753

Last Updated: 2020-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5940299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Organic Disorders

Intervention Type OTHER

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 Disorders

Intervention Type OTHER

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 Disorders

Intervention Type OTHER

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 disorders

Intervention Type OTHER

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 disorders

Intervention Type OTHER

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 Disorders

Intervention Type OTHER

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 Disorders

Intervention Type OTHER

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 Disorders

Intervention Type OTHER

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 Disorders

Intervention Type OTHER

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 Disorders

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John J McGrath, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Centre for Register-Based Research, Aarhus University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32348643 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COMO-GMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.