Lithium Versus Anticonvulsants and the Risk of Physical Disorders - Results From a Comprehensive Long-term Nation-wide Population-based Study Emulating a Randomised Trial
| Registry | NCT06005155 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 169285 (Actual) |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital (Other) |
| Conditions | Bipolar Disorder |
| Interventions | Lithium (Drug) |
| Dates | start 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 in Denmark |
Related Papers Related Patents Related Grants Related Experts
All trials for Bipolar Disorder All trials of Lithium
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.
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.
Sex: All, ages: 5 Years to 100 Years
Inclusion Criteria: * diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate Exclusion Criteria: * None
| Facility | City | Country | Status |
|---|---|---|---|
| Psychiatric Center Copenhagen | Copenhagen | Denmark |