NCT06005155

Lithium Versus Anticonvulsants and the Risk of Physical Disorders

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 169,285 (actual)
• Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Lithium	Sustained long-term exposure

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2023-08-22
• Last updated: 2023-08-22

Locations

1 site across 1 country: Denmark