Lithium Versus Anticonvulsants and the Risk of Physical Disorders

NCT ID: NCT06005155

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 169285 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-07-01

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.

Conditions

Bipolar Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Lithium

Sustained long-term exposure

Intervention Type: DRUG

Other Intervention Names

Lamotrigene; Valproate

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars V Kessing, Professor

Role: PRINCIPAL_INVESTIGATOR

Psychiatric Center Copenhagen

Locations

Psychiatric Center Copenhagen

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

Lithium versus anticonvulsants

Identifier Type: -

Identifier Source: org_study_id