NCT06005155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169,285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

August 15, 2023

Last Update Submit

August 21, 2023

Conditions

Bipolar Disorder

Keywords

LithiumLamotrigerneValproatePhysical disorders

Outcome Measures

Primary Outcomes (10)

  • Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Arteriosclerosis

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Angina pectoris

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Myocardial infarction

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Myxoedema

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Osteoporosis

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Dementia (separately for Alzheimer's disease and other dementia)

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Parkinson's disease

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

  • Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)

    Diagnosis in the Danish National Hospital Register

    1997 to 2021

Interventions

LithiumDRUG

Sustained long-term exposure

Also known as: Lamotrigene, Valproate

Eligibility Criteria

Age5 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Center Copenhagen

Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

LithiumValproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Lars V Kessing, Professor

    Psychiatric Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

June 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

DK(1)