Clinical trial NCT06005155: Lithium Versus Anticonvulsants and the Risk of Physical Disorders
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Lithium
Lamotrigerne
Valproate
Physical disorders
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 169285
Sex: ALL
Minimum age (years): 5
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nationwide population-based register linkage study covering the entire 5.9 million inhabitants in Denmark and 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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)
timeFrame: 1997 to 2021
measure: Arteriosclerosis
timeFrame: 1997 to 2021
measure: Angina pectoris
timeFrame: 1997 to 2021
measure: Myocardial infarction
timeFrame: 1997 to 2021
measure: Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)
timeFrame: 1997 to 2021
measure: Myxoedema
timeFrame: 1997 to 2021
measure: Osteoporosis
timeFrame: 1997 to 2021
measure: Dementia (separately for Alzheimer's disease and other dementia)
timeFrame: 1997 to 2021
measure: Parkinson's disease
timeFrame: 1997 to 2021
measure: Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)
timeFrame: 1997 to 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Center Copenhagen
Study officials:
affiliation: Psychiatric Center Copenhagen
name: Lars V Kessing, Professor
role: PRINCIPAL_INVESTIGATOR
References: