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Clinical trial

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

ID
Name
Lithium versus anticonvulsants
Description
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.
Trial arms
Trial start
2022-06-01
Estimated PCD
2023-07-01
Trial end
2023-07-01
Status
Completed
Treatment
Lithium
Sustained long-term exposure
Other names:
Lamotrigene, Valproate
Size
169285
Primary endpoint
Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)
1997 to 2021
Arteriosclerosis
1997 to 2021
Angina pectoris
1997 to 2021
Myocardial infarction
1997 to 2021
Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)
1997 to 2021
Myxoedema
1997 to 2021
Osteoporosis
1997 to 2021
Dementia (separately for Alzheimer's disease and other dementia)
1997 to 2021
Parkinson's disease
1997 to 2021
Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)
1997 to 2021
Eligibility criteria
Inclusion Criteria: * diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate Exclusion Criteria: * None
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 169285, 'type': 'ACTUAL'}}
Updated at
2023-08-22

1 organization

1 product

1 indication

Organization
Mental Health Services in the Capital Region
Product
Lithium
Indication
Bipolar Disorder