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

Covid19 Clinical Trial

Official title:

COVID-19 Serological Testing of Patients With a Diagnosis of Schizophrenia, Schizoaffective Disorder or Bipolar Affective Disorder From the Catchment Area of the Capital Region of Denmark

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04775407
• Other study ID #: COVID-19 RHP
• Status: Terminated
• Start date: January 18, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2022
• Source: Psychiatric Centre Rigshospitalet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1355
• Est. completion date: June 1, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Disease
• Mental Disorders
• Psychotic Disorders
• Severe Mental Disorder

Intervention

Procedure:
• blood sampling
IgM og IgG analysis

Locations

Country	Name	City	State
Denmark	Psychiatric Centre Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Anders Fink-Jensen, MD, DMSci

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of positive serological COVID-19 test result	A blood sample from each patient is analyzed for COVID-19 antibodies	18 month
Secondary	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	18 month