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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06005155
Enrollment
169285
Registered
2023-08-22
Start date
2022-06-01
Completion date
2023-07-01
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Lithium, Lamotrigerne, Valproate, Physical disorders

Brief 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.

Interventions

DRUGLithium

Sustained long-term exposure

Sponsors

Mental Health Services in the Capital Region, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)1997 to 2021Diagnosis in the Danish National Hospital Register
Arteriosclerosis1997 to 2021Diagnosis in the Danish National Hospital Register
Angina pectoris1997 to 2021Diagnosis in the Danish National Hospital Register
Myocardial infarction1997 to 2021Diagnosis in the Danish National Hospital Register
Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)1997 to 2021Diagnosis in the Danish National Hospital Register
Myxoedema1997 to 2021Diagnosis in the Danish National Hospital Register
Osteoporosis1997 to 2021Diagnosis in the Danish National Hospital Register
Dementia (separately for Alzheimer's disease and other dementia)1997 to 2021Diagnosis in the Danish National Hospital Register
Parkinson's disease1997 to 2021Diagnosis in the Danish National Hospital Register
Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)1997 to 2021Diagnosis in the Danish National Hospital Register

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026