Lithium Versus Anticonvulsants and the Risk of Physical Disorders

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT06005155
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-22
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169285

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Psychiatric Center Copenhagen; 🇩🇰 Copenhagen, Denmark