Lithium compared with lamotrigine for a type of bipolar disorder
Compares lithium and lamotrigine for mood stability in bipolar disorder.
Key facts
- Who runs it
- Region Hovedstaden
- Where
- Copenhagen Nv, DenmarkSee the site
- Trial code
- EU 2023-509607-32-00
- U1111-1300-4501
- Registry title
- The LiLa-Bipolar RCT
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 200 people, planned
- Started
- 29 Apr 2024
- Expected to end
- 1 Dec 2027
- Type of study
- Interventional
- Record updated
- 10 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed bipolar disorder, type II. It compares lithium with lamotrigine over 6 months.
- Age
- 18-70 years
- Sex
- All sexes can join.
- Disease stage
- Bipolar disorder, type II, with the diagnosis confirmed by a SCAN interview. People can join during a depressive state, a hypomanic state, or full or partial remission.
- Earlier treatment
- People cannot join if they did not respond to, or could not tolerate, lamotrigine or lithium after more than 6 weeks at an adequate dose. People cannot join if they are currently taking mood stabilizers at enrollment.
Main reasons for not taking part
- Past non-response or intolerance to lamotrigine or lithium (more than 6 weeks at an adequate dose)
- Currently taking mood stabilizers at enrollment
- Chronic kidney disease with GFR 0-10 ml/min
- Severe cardiac insufficiency (NYHA IIIb-IV)
- Brugada's syndrome
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- All patients referred to the clinic as newly diagnosed with BDII will routinely be asked for inclusion in the RCT. Patients are included during 1) depressive state, 2) hypomanic state or 3) full or partial remission
- Bipolar disorder, type II with diagnoses confirmed by SCAN interview
- Age 18-70 years
- Speaks and writes Danish or English at a level equal to mother tongue
- Habile (i.e., able to give informed consent)
Who cannot take part
- Currently taking mod stabilizers at enrollment in CADIC
- Severe cardiac insufficiency (NYHA IIIb-IV)
- Brugadas syndrome
- Chronic kidney disease with GFR 0-10 ml/min
- Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatment at an adequate dosage
- Severe hypothyroidism despite treatment
Where in Denmark
- Psykiatrisk Center KobenhavnCopenhagen Nv, DenmarkTaking people
About the trial
What the trial wants to find out
Lithium versus Lamotrigine in bipolar disorder, type II – a single blinded randomized controlled trial (the LiLa-Bipolar RCT). To conduct a 6-month RCT comparing effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse. Primary hypothesis: Lithium improves mood stabilization compared with lamotrigine.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Lithium versus Lamotrigine in bipolar disorder, type II – a single blinded randomized controlled trial (the LiLa-Bipolar RCT)
- Plain-language title
- Lithium compared with lamotrigine for a type of bipolar disorderGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 10 March 2026