Bipolar DisorderNCT06005155
Lithium Versus Anticonvulsants and the Risk of Physical Disorders
An observational study of Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 5 to 100 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lithium
- How many people
- 169,285 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2022to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Lithium
- Keywords
- Lithium, Lamotrigerne, Valproate, Physical disorders
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Also called Lamotrigene, Valproate
Sustained long-term exposure
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Arteriosclerosis
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Angina pectoris
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Myocardial infarction
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Myxoedema
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Osteoporosis
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Dementia (separately for Alzheimer's disease and other dementia)
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Parkinson's disease
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)
Diagnosis in the Danish National Hospital Register
Measured: 1997 to 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Jun 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 169,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars V Kessing, Professor, Principal investigator, Psychiatric Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005155
- Sponsor's protocol ID
- Lithium versus anticonvulsants
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06005155
- Acronym / sponsor ID
- Lithium versus anticonvulsants
- Conditions
- Bipolar Disorder
- Keywords
- Lithium, Lamotrigerne, Valproate, Physical disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169,285 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- diagnosis of bipolar disorder and subsequent exposure to either lithium, lamotrigine or valproate
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LithiumAlso: Lamotrigene, ValproateSustained long-term exposure | Drug | – |
Primary outcome
Incident stroke (separately for intracerebral hemorrhage and cerebral infarction)
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Arteriosclerosis
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Angina pectoris
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Myocardial infarction
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Diabetes mellitus (separately for type 1 diabetes and type 2 diabetes)
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Myxoedema
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Osteoporosis
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Dementia (separately for Alzheimer's disease and other dementia)
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Parkinson's disease
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Chronic kidney disease (definite chronic kidney disease and possible Chronic kidney disease)
Time frame: 1997 to 2021
Diagnosis in the Danish National Hospital Register
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars V Kessing, Professor principal investigator
Psychiatric Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident stroke (separately for intracerebral hemorrhage and cerebral infarction) (time frame: 1997 to 2021). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.