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Lithium Versus Anticonvulsants and the Risk of Physical Disorders

Bipolar Disorder Clinical Trial

Official title:
Lithium Versus Anticonvulsants and the Risk of Physical Disorders - Results From a Comprehensive Long-term Nation-wide Population-based Study Emulating a Randomised Trial

Clinical Trial Summary

Nationwide population-based register linkage study covering the entire 5.9 million inhabitants in Denmark systematically investigating the associations between sustained long-term use of lithium versus lamotrigine and valproate, and the risk of a range of physical disorders emulating a randomized trial.

Clinical Trial Description

The study includes two cohorts. Cohort 1: all 12.607 patients with a diagnosis of bipolar disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium, lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of prior diagnosis of bipolar disorder (N= 156.678). Main analyses considered a patient exposed to a drug 92 days after a prescription and a 10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60 and 180 days after a prescription, respectively, and with 5- and 15-years follow-up, respectively. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06005155
Study type Observational
Source Mental Health Services in the Capital Region, Denmark
Contact
Status Completed
Phase
Start date June 1, 2022
Completion date July 1, 2023
View Details
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