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TerminatedNCT04775407Updated Sep 7, 2022

COVID-19 Serological Testing of Patients With a Mental Disorder From the Catchment Area of the Capital Region of Denmark

An observational study in Covid19 and Severe Mental Disorder, sponsored by Anders Fink-Jensen, MD, DMSci. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by Anders Fink-Jensen, MD, DMSci · Observational

Why this study was terminated
Due to the development of the pandemic
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,355
Ages
18 Years and older
Sex
All
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Study summary

The pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has lately caused worldwide health problems. Patients suffering from a severe mental disorder are at increased risk for infectious diseases. The primary aim of the present surveillance study is to perform COVID-19 serological testing on patients with a diagnosis of schizophrenia, schizoaffective disorder or a bipolar affective disorder. Patients from the catchment area of the Capital Region of Denmark will be COVID-19 tested at baseline (0 months) and again at 6 and 12 months, in order to follow the spread of COVID-19 among this vulnerable patient population.

Read the detailed description

Patients suffering from severe mental illness could be in increased risk for a severe outcome if infected with COVID-19. Also, there are reports on fewer treatment activities among psychiatric patients (e.g. higher heart disease mortality), lower hospitalization rate and fewer invasive cardiac procedures among persons with schizophrenia than among the general population. This conveys a risk not only for the patient but for the spread of COVID-19 in the community. At present, we expect the outcome of a COVID-19 infection to be worse among the mentioned psychiatric patient population, but whether the spread of COVID-19 differs from the pattern observed in the general population is unknown. This information is of pivotal interest to come up with sufficient treatment strategies - especially when facing a possible second surge in the COVID-19 spread. Moreover, it is to the best of our knowledge unknown whether a possible CNS COVID-19 infection will worsen existing psychopathology among patients with severe schizophrenia, schizoaffective- or bipolar affective disorder. The study is exploratory in nature including as many patients as possible for testing. The target population is patients diagnosed with schizophrenia, schizoaffective disorder or a bipolar affective disorder receiving in-patient or out-patient care via one of the psychiatric centres in The Mental Health Services in the Capital Region of Denmark. Each patient will attend 3 study visits during a period of 12 months. A blood sample for IgG and IgM analysis for will be drawn at every visit.

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Conditions studied

  • Covid19
  • Severe Mental Disorder
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In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,355 is above the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Anders Fink-Jensen, MD, DMSci is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The target population is patients diagnosed with schizophrenia, schizoaffective disorder or a bipolar affective disorder receiving in-patient or out-patient care via one of the psychiatric centres in The Mental Health Services in the Capital Region of Denmark

Inclusion criteria

  1. Informed oral and written consent
  2. Age ≥ 18 years
  3. Patients with a diagnosis of schizophrenia, schizoaffective disorder or a bipolar affective disorder, according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO))
  4. Receiving psychiatric treatment from a hospital in- or outpatient-clinic in the catchment area of the Capital Region of Denmark

Exclusion criteria

Exclusion Criteria:

  1. Patient with signs of infection should initially be transferred to the national test centres antigen-PCR testing. These patients will be offered to participate in next blood sampling interval.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,355 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Screening

    Serological SARS-CoV-2 test

    Procedure: blood sampling

Interventions

  • Procedureblood sampling

    IgM og IgG analysis

06

What researchers measure

Primary outcomes

  1. The incidence of positive serological COVID-19 test result

    A blood sample from each patient is analyzed for COVID-19 antibodies

    Time frame: 18 month

Secondary outcomes

  1. Registered death (number), hospital admissions (number), changes in out-patients clinic contacts (number), changes in suicidal behavior (score on medical scale) and changes in psychopharmacological treatment (registered changed in medial journal).

    Data from Danish registers and from patient medical records are correlated with the possible presence of COVID-19 antibodies

    Time frame: 18 month

07

Study locations

1 site
  • Psychiatric Centre Copenhagen
    Copenhagen, 2100, Denmark
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References and documents

Publications

  • Sass MR, Juul TS, Skov R, Iversen K, Harritshoj LH, Sorensen E, Ostrowski SR, Andersen O, Ekstrom CT, Ullum H, Nielsen J, Hageman I, Fink-Jensen A. SARS-CoV-2 seroprevalence among patients with severe mental illness: A cross-sectional study. PLoS One. 2022 Mar 1;17(3):e0264325. doi: 10.1371/journal.pone.0264325. eCollection 2022. PubMed 35231037 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04775407
Lead sponsor
Anders Fink-Jensen, MD, DMSci
Responsible party
Anders Fink-Jensen, MD, DMSci (MD Proffessor, Psychiatric Centre Rigshospitalet) — Sponsor-investigator
First posted
Mar 1, 2021
Start date
Jan 18, 2021
Primary completion
Feb 20, 2021
Completion
Jun 1, 2021
Last update
Sep 7, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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