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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04409626
Other study ID # REG-2020-05-05
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date August 2020

Study information

Verified date May 2020
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study seeks to investigate if hyponatraemia be a direct contributor to death in schizophrenic and bipolar patients, and gauge the potential role of somatic comorbidity and psychotropic polypharmacy, with emphasis on antipsychotics and antidepressants.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 31740
Est. completion date August 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Source population:

- Danish residents

- At least one International Classification of Diseases version 10 (ICD-10) F2 or F31 diagnosis from a hospital in Region Zealand and the Capital Region (Denmark)

No exclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Plasma sodium level (continuous variables)
Observational study, so the exposures of interest (5-year mean and minimum plasma sodium) are not administered to the patients. Ultimately, our interest is in hyponatraemia.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zealand University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality All-cause mortality 1 January 2011 through 1 July 2016
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