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NCT Number: NCT06005155

Lithium Versus Anticonvulsants and the Risk of Physical Disorders

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

5 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Psychiatric Center Copenhagen

Copenhagen, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Lithium

Drug

Sustained long-term exposure

Other names: Lamotrigene, Valproate

Primary outcomes

  1. Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

  2. Arteriosclerosis

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

  3. Angina pectoris

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

  4. Myocardial infarction

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

  5. Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

  6. Myxoedema

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

  7. Osteoporosis

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

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

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

  9. Parkinson's disease

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

  10. Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)

    Time frame: 1997 to 2021

    Diagnosis in the Danish National Hospital Register

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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