NCT03847753: COMO-GMC

Exploring the Comorbidity Between Mental Disorders and General Medical Conditions

Completed Last updated 22 May 2020

What this trial tests

trial testing Organic Disorders in Organic, Including Symptomatic, Mental Disorders in 5,940,299 participants. Completed in 31 January 2020.

Timeline

1 January 2000

Primary endpoint
31 December 2016

31 January 2020

Quick facts

Lead sponsor	University of Aarhus
Status	Completed
Study type	OBSERVATIONAL
Enrollment	5,940,299
Start date	1 January 2000
Primary completion	31 December 2016
Estimated completion	31 January 2020

Drugs / interventions tested

• Organic Disorders
• Substance Use Disorders
• Schizophrenia Disorders
• Mood disorders
• Neurotic disorders
• Eating Disorders
• Personality Disorders
• Intellectual Disorders
• Developmental Disorders
• Behavioral Disorders

Conditions studied

• Organic, Including Symptomatic, Mental Disorders — all drugs for Organic, Including Symptomatic, Mental Disorders →
• Substance Use — all drugs for Substance Use →
• Schizophrenia — all drugs for Schizophrenia →
• Mood [Affective] Disorders — all drugs for Mood [Affective] Disorders →

Sponsor

University of Aarhus

Who can join

1 and older, any sex, with Organic, Including Symptomatic, Mental Disorders or Substance Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association between Mental Disorders and Subsequent Medical Conditions.
   Momen NC, Plana-Ripoll O, Agerbo E, Benros ME, et al · · 2020 · cited 356× · PMID 32348643 · DOI 10.1056/nejmoa1915784