Lithium Versus Anticonvulsants and the Risk of Physical Disorders

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06005155
• Other study ID #: Lithium versus anticonvulsants
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169285
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Lithium
Sustained long-term exposure

Locations

Country	Name	City	State
Denmark	Psychiatric Center Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Arteriosclerosis	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Angina pectoris	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Myocardial infarction	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Myxoedema	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Osteoporosis	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Dementia (separately for Alzheimer's disease and other dementia)	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Parkinson's disease	Diagnosis in the Danish National Hospital Register	1997 to 2021
Primary	Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)	Diagnosis in the Danish National Hospital Register	1997 to 2021